A Certificate of Free Sale asserts a product or substance being brought into a country complies with U.S. laws for distribution and/or sale in domestic commerce. The form assures the importing country that the product has been inspected and approved in accordance with regulations of the USDA and that the product or substance is fit for human consumption.

Moreover, a certified product bears an official mark of inspection and is approved for domestic commerce. For additional information, call the Office of International Affairs at (202) 720-3473.

View the Certificate

[ Read More ]

[ Read More ]

A great deal of controversy has unnecessarily lingered for decades regarding the alleged lack of safety regarding Germanium-132 and its inclusion in dietary supplements. Much of this misinformation can be attributed to mistakes made years ago concerning the accidental or careless classification of organic germanium-132 (bis beta-carboxyethyl germanium sesquioxide) as being analogous or the same thing as elemental Germanium–a toxic metalloid utilized in a variety of industrial applications.

This false conclusion stems primarily from several unfortunate incidents occurring several decades ago. Basically, a handful disreputable manufacturers imported impure quantities of Germanium-132, that had been tainted with the elemental form perhaps to save money or increase their “product” volume, from Asian sources and a few subsequent deaths occurred.

The complete truth is—the organic form of Germanium-132 (in untainted, pure samples) has never caused any negative health reactions, illness, or death.

In clinical research, organic Germanium-132 has demonstrated efficacy for:

• Lowering or stabilizing blood pressure and serum cholesterol (LDL)
• Stimulating Interferon production (to block HIV virus replication)
• Encouraging suppressor T-Cell and NK-Lymphocyte production
• Activating dormant Macrophages to kill cytotoxins
• Promoting attraction and efficient absorption of oxygen by various bodily organs
• Protecting against radiation damage and free radicals
• Inhibiting the growth of harmful flora and invading organisms
• Rejuvenating development of blood vessels for improved vision
• Helping the body retain bone density while reducing sensitivity
• Diminishing parathyroid secretions leading to decreased bone strength
• Acting as a potent pain relieving agent

Essentially, organic Germanium-132 boosts the immune system by activating dormant macrophages to phagocytize (digest) cellular debris and viruses and also motivate other immune cells into action. This organic mineral may also provide some benefit as well for improved neural response and resistance to germs. Many alternative health practitioners and experienced researchers assert all disease results directly from the under-oxygenation of cellular tissue; and Germanium-132 greatly enhances both the presence and absorption of oxygen in the body’s various organs.

Although you may not be used to reading empirical data-oriented research, the clinical studies below provide verifiable information regarding both the safety and efficacy of Germanium-132 for supporting the immune system and natural body processes against a variety of negative health conditions. Criteria for these type of studies include the application of unbiased observation methods without adherence to preconceptions, strict protocols of the scientific method for experimental design, and most importantly, results that can be reproduced (and thus measured) over and over again.

In other words, these data cannot be refuted easily, not without presenting conflicting findings for peer review along with detailed explanations of why the earlier experiment failed in some respect. At the very least, the articles below provide a starting point for further study and consideration of this effective and safe health-promoting mineral.

Immunological control of methicillin-resistant Staphylococcus aureus (MRSA) infection in an immunodeficient murine model of thermal injuries.

Summary: GE-132 Can Protect Against MRSA Infections.

“Staphylococcus aureus, especially methicillin-resistant S. aureus (MRSA), is a major cause of sepsis in patients who are immunosuppressed by their burns. In this study, an immunological regulation of MRSA infection was attempted in a mouse model of thermal injury. SCIDbg mice were resistant to MRSA infection, while SCIDbgMN mice (SCIDbg mice depleted of neutrophils and macrophages (Mphi)) were susceptible to the same infection. Also, thermally injured SCIDbg mice were shown to be susceptible to MRSA infection. On the other hand, the resistance of SCIDbgMN mice to the infection was completely recovered after an inoculation with Mphi from normal mice.

However, anti-MRSA resistance was not shown in SCIDbgMN mice inoculated with Mphi from thermally injured mice. Mphi from MRSA-infected thermally injured mice were identified as alternatively activated Mphi, and Mphi from MRSA-infected unburned mice were characterized as classically activated Mphi.

Mphi from thermally injured SCIDbg mice previously treated with 2-carboxyethylgermanium sesquioxide (Ge-132) protected SCIDbgMN mice against MRSA infection. Ge-132 has been described as an inhibitor of alternatively activated Mphi generation. These results suggest that MRSA infection in thermally injured patients is controlled immunologically through the induction of anti-MRSA effector cells and elimination of burn-associated alternatively activated Mphi, which are cells that inhibit the generation of classically activated Mphi.”^[1]

Department of Internal Medicine, The University of Texas Medical Branch
Galveston, Texas 77555-0435, USA.

^[1]Katakura, T., Yoshida, T., Kobayashi, M., Herndon, D. N. and F. Suzuki. “Immunological control of methicillin-resistant Staphylococcus aureus (MRSA) infection in an immunodeficient murine model of thermal injuries.”
Clinical and experimental immunology. Vol. 142, Issue 3. (419-25). Dec 2005. Online. Accessed: 9 May 2007. (Highlighted text by The Editors).
Available: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?CMD=search&DB=pubmed PMID: 16297152 [PubMed - indexed for MEDLINE]

DNA binding specificity and cytotoxicity of novel antitumor agent Ge132 derivatives.

Summary: GE-132 Shows Enhanced Anti-Tumor Activity.

“A series of Ge132 derivatives have shown enhanced anti-tumor activity. Previous studies suggest that DNA can be their primary target. Here we show direct evidence that two newly synthesized Ge132 derivatives can intercalate into DNA. Unexpected methyl substitution effect of the novel derivatives on DNA sequence selectivity and cytotoxicity was observed.”^[1]

Division of Biological Inorganic Chemistry
Key Laboratory of Rare Earth Chemistry and Physics
Graduate School of the Chinese Academy of Sciences
Changchun Institute of Applied Chemistry
Chinese Academy of Sciences
Changchun, Jilin 130022, China.

^[1]Shangguan, G., Xing, F., Qu, X., Mao, J., Zhao, D., Zhao, X. and J. Ren. “DNA binding specificity and cytotoxicity of novel antitumor agent Ge132 derivatives.”
Bioorganic & medicinal chemistry letters. Vol. 15, Issue 12. (2962-5). 2005 Jun 15. Online. Accessed: 9 May 2007. (Highlighted text by The Editors).
Available: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?CMD=search&DB=pubmed PMID: 15914003 [PubMed - indexed for MEDLINE]

Prevention of trabecular bone loss in the mandible of ovariectomized rats.

Summary: GE-132 Shows Increased Bone Mineral Density and Bone Mineral Content.

“The effect of therapeutic agents on trabecular bone loss in the mandible was investigated in ovariectomized rats. Eighty-seven Wistar SPF female rats were ovariectomized (OVX) or given a sham operation (Sham), and maintained on a diet containing 0.1% calcium. Four weeks later, groups of OVX rats were treated with estriol (E3), calcitonin (CT), etidronate, or 2-carboxyethylgermanium sesquioxide (Ge-132).

The Basal group was maintained on a diet containing 1.0% calcium, and the OVX and sham groups on a diet containing 0.1% calcium. The trabecular bone mineral density (BMD) and trabecular bone mineral content (BMC) in 11 mandibular slices from 0.5 mm at the mesial margin of the first molar to 0.5 mm at the distal margin of the third molar, were measured using peripheral Quantitative Computed Tomography (pQCT).

The BMD in the OVX group was lower than that in the Sham group, and decreased BMC was observed only in the molar region. BMD and BMC were increased in the etidronate-treated group, but only BMC was increased in the CT group. E3 treatment increased BMD and BMC; significant increases were also observed beneath the molar. Ge-132 treatment increased both BMD and BMC, especially the latter.“^[1]

Department of Pharmacology, Nihon University School of Dentistry at Matsudo
Chiba, Japan.

^[1]Jiang, G., Matsumoto, H., Yamane, J., Kuboyama, N., Akimoto, Y. and A. Fujii. “Prevention of trabecular bone loss in the mandible of ovariectomized rats.”
Journal of oral science. Vol. 46, Issue 2. Jun 2004. (75-85). Online. Accessed: 9 May 2007. (Highlighted text by The Editors).
Available: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?CMD=search&DB=pubmed PMID: 15287540 [PubMed - indexed for MEDLINE]

Germane facts about germanium sesquioxide:
I. Chemistry and anticancer properties.

Summary: GE-132 – Anti-Cancer Properties and why more Studies have not been Performed!

“This paper reviews the history, chemistry, safety, toxicity, and anticancer effects of the organogermanium compound bis (2-carboxyethylgermanium) sesquioxide (CEGS). A companion review follows, discussing the inaccuracies in the scientific record that have prematurely terminated research on clinical uses of CEGS. CEGS is a unique organogermanium compound first made by Mironov and coworkers in Russia and, shortly thereafter, popularized by Asai and his colleagues in Japan.

Low concentrations of germanium occur in nearly all soils, plants and animal life; natural occurrence of the CEGS form is postulated but not yet demonstrated. The literature demonstrating its anticancer effect is particularly strong: CEGS induces interferon-gamma (IFN-gamma), enhances natural killer cell activity, and inhibits tumor and metastatic growth–effects often detectable after a single oral dose.

In addition, oral consumption of CEGS is readily assimilated and rapidly cleared from the body without evidence of toxicity. Given these findings, the absence of human clinical trials of CEGS is unexpected. Possible explanations of why the convincing findings from animal research have not been used to support clinical trials are discussed. Clinical trials on CEGS are recommended.”^[1]

Department of Paediatrics (and)
Department of Community Health Sciences
Faculty of Medicine, University of Calgary (with)
Alberta Children’s Hospital
Calgary, Alberta, Canada
kaplan@ucalgary.ca

^[1]Kaplan, B. J., Parish, W. W., Andrus, G. M., Simpson, J. S. and C. J. Field. “Germane facts about germanium sesquioxide: I. Chemistry and anticancer properties.”
Journal of alternative and complementary medicine. Vol. 10, Issue 2. Apr 2004. (337-44). Online. Accessed: 9 May 2007. (Highlighted text by The Editors).
Available: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?CMD=search&DB=pubmed PMID: 15165414 [PubMed - indexed for MEDLINE]

Germane facts about germanium sesquioxide:
II. Scientific error and misrepresentation.

“The preceding paper reviewed the anticancer properties and safety of bis (2-carboxyethylgermanium) sesquioxide (CEGS). An examination of those data leads one to question why this information has not stimulated clinical trials in patients with cancer. The answer is discussed in this paper, which traces the history to an error published in the scientific literature in 1987.

The reliance by subsequent authors on secondary sources, citing only the error and not the correction published in 1988, constitutes part of the explanation of why CEGS has been neglected. A second factor is also considered: careless reporting about any germanium-based compound as if the many thousands of germanium compounds were all the same. This combination of a publication error, careless writing, and the reliance on secondary sources appears to be responsible for the neglect of the potential clinical use of this unique germanium compound.”^[1]

Department of Paediatrics (and)
Department of Community Health Sciences
Faculty of Medicine, University of Calgary (with)
Alberta Children’s Hospital
Calgary, Alberta, Canada
kaplan@ucalgary.ca

^[1]Kaplan, B. J., Andrus, G. M. and W. W. Parish. “Germane facts about germanium sesquioxide: II. Scientific error and misrepresentation.”
Journal of alternative and complementary medicine. Vol. 10, Issue 2. Apr 2004 (345-8). Online. Accessed: 9 May 2007. (Highlighted text by The Editors).
Available: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?CMD=search&DB=pubmed PMID: 15165415 [PubMed - indexed for MEDLINE]

[Studies on the hydroxyl free radical-scavenging effect of combined selenium and germanium.]

[Article in Chinese]

Summary: GE-132 – Free Radical Scavenging Ability with Selenium!

“The effect of selenium, carboxyethyl-germanium sesquioxide (Ge-132) and the combination of selenium and Ge-132 on the production of hydroxyl free radical in liver microsomes of rats treated with Fe2SO4-NADPH system was studied with electron spin resonance technique (ESR). The results showed that the production of hydroxyl free radical was decreased significantly by adding selenium, Ge-132 and combined selenium and Ge-132, indicating a direct scavenging effect on hydroxyl free radical. It was also observed a enhanced scavenging effect at the low concentration of combined selenium and Ge-132.”^[1]

Tongji Medical College, Huazhong University of Science and Technology
Wuhan 430030, China.

^[1]Wu, Z., Chen, X., Yang, K. and T. Xia. “[Studies on the hydroxyl free radical-scavenging effect of combined selenium and germanium].” (Article in Chinese).
Wei sheng yan jiu. (Journal of hygiene research.) Vol. 30, Issue 4. Jul 2001 (208-10). Online. Accessed: 9 May 2007. (Highlighted text by The Editors).
Available: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?CMD=search&DB=pubmedPMID: 12561515 [PubMed - in process]

2-Carboxyethylgermanium sesquioxide, a synthetic organogermanium compound, as an inducer of contrasuppressor T cells.

Summary: GE-132 Induces Contrasuppressor T-Cell Activity!

“2-Carboxyethylgermanium sesquioxide (Ge-132), a synthesized organogermanium compound with immunomodulating activities, was shown to be an inducer of anti-suppressor T cells in normal mice. The suppressor cell activity of T6S cells, a clone of burn-induced CD8+ IL-4-producing suppressor T cells, was clearly inhibited when a mixed lymphocyte-tumor cell reaction of the clone was conducted with splenic mononuclear cells from mice treated orally with a 100 mg/kg dose of Ge-132. The activity of anit-suppressor cells was demonstrated in spleens of mice 2 days after treatment with Ge-132 and reached its peak on day 3.

The anti-suppressor cells induced by the compound were of a contrasuppressor T cell-linage, because they were characterized as CD4+ CD28+ TCRalpha/beta+ Vicia villosa lectin-adherent T cells. These cells produced IFN-gamma but did not produce IL-2, IL-4, IL-6 or IL-10 in their culture fluids. CD4+ anti-suppressor T cells induced by Ge-132 may be different from other subsets of CD4+ T cells because Th1 and Th2 cells generated in our laboratory did not adhere to Vicia villosa lectin-coated petri dishes, and each produced specific cytokines.

Th1 cells produced IFN-gamma and IL-2 while Th2 cells produce IL-4 and IL-10 in vitro. These results suggest that Ge-132 may be useful as an inducer of contrasuppressor T cells in immunocompromised individuals bearing suppressor T cells. To eliminate suppressor T cells from immunocompromised hosts may result in improved resistance from various opportunistic infections.“^[1]

Department of Neurology
Yamaguchi University of Medical School
Japan.

^[1]Ikemoto, K., Kobayashi, M., Fukumoto, T., Morimatsu, M., Pollard R. B. and F. Suzuki. “2-Carboxyethylgermanium sesquioxide, a synthetic organogermanium compound, as an inducer of contrasuppressor T cells.”
Experientia. Vol. 52, Issue 2. Feb 1996 (159-66). Online. Accessed: 9 May 2007. (Highlighted text by The Editors).
Available: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?CMD=search&DB=pubmedPMID: 8608818 [PubMed - indexed for MEDLINE]

Effect of organic germanium compound (Ge-132) on experimental osteoporosis in rats.

Summary: GE-132 – May be Beneficial for Osteoporosis!

“The therapeutic effect of organic germanium compound, 2-carboxyethylgermaniumsesquioxide (Ge-132), for experimental osteoporosis was studied using ovariectomized rats maintained on a low calcium containing diet. 2. Serum calcitonin (sCT) level was decreased and serum parathyroid hormone (sPTH) level was increased by ovariectomy and the decrement and increment rates, respectively, were reduced by administration of Ge-132.

Thus, the sCT/sPTH ratio was greater in the groups given Ge-132, indicating that the resorption [sic] was somehow inhibited by Ge-132. 3. The transverse strength of femur bone was significantly enhanced by Ge-132. 4. A trend was found in the group given Ge-132 for a larger femur cortical bone index. 5. The relative femur bone wet weight was greater in the group given Ge-132. 6. These results indicate that Ge-132 prevents decreased bone strength, and affects the femur cortical bone index, and bone mineral mass caused by osteoporosis.“^[1]

Department of Pharmacology
Nihon University School of Dentistry
Chiba, Japan.

^[1]Fujii, A., Kuboyama, N., Yamane, J., Najao, S. and Y. Furukawa. “Effect of organic germanium compound (Ge-132) on experimental osteoporosis in rats.”
General pharmacology. Vol. 24, Issue 6. Nov 1993 (1527-32). Online. Accessed: 9 May 2007. (Highlighted text by The Editors).
Available: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?CMD=search&DB=pubmed PMID: 8112531 [PubMed - indexed for MEDLINE]

Antiviral activity of carboxyethylgermanium sesquioxide (Ge-132) in mice infected with influenza virus.

Summary: GE-132 – Immunomodulating activities. May have Anti-Viral Properties.

“The protective effect of carboxyethylgermanium sesquioxide (Ge-132) in mice infected with a mouse-adapted strain of influenza virus (H2N2) was investigated. When mice were exposed to a 10 LD50 dose of influenza virus via aerosol and were treated orally with 20 or 100 mg/kg of Ge-132 daily for 6 consecutive days, a significant protective effect was demonstrated.

The antiviral effect of Ge-132 was indicated by an increase of survivors, a prolongation of mean survival days, an inhibition of the development of lung consolidation, and a decrease of virus titer in lung tissues, as compared to infected control mice treated with phosphate-buffered saline.

Natural killer (NK) cell activity in the spleens and lungs of the infected mice was also significantly augmented after the oral administration of Ge-132. In addition, NK cells stimulated with Ge-132 in vivo showed killing activity against NK-insensitive Meth-A cells infected with influenza virus.

Because no virucidal or virustatic activities of Ge-132 on the virus were found in vitro, this protective effect in mice against influenza virus infection may be displayed through immunomodulating activities of this compound such as the augmentation of NK cell activity.“^[1]

Department of Bacteriology
Tohoku University School of Medicine
Sendai, Japan.

^[1]Aso, H., Suzuki, F., Ebina, T. and N. Ishida. “Antiviral activity of carboxyethylgermanium sesquioxide (Ge-132) in mice infected with influenza virus.”
Journal of biological response modifiers. Vol. 8, Issue 2. Apr 1989 (180-9). Online. Accessed: 11 May 2007. (Highlighted text by The Editors).
Available: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?CMD=search&DB=pubmed PMID: 2471817 [PubMed - indexed for MEDLINE]

Induction of interferon production by natural killer cells by organogermanium compound, Ge132.

Summary: GE-132 – Study shows increased Interferon production by Natural Killer Cells.

“Interferon (IFN)-inducing activity of the organogermanium compound Ge132 in human peripheral mononuclear cells was investigated. By using Percoll discontinuous density gradient centrifugation, peripheral blood nonphagocytic and nonadherent mononuclear cells were divided into the low-and high-density fractions. Natural killer (NK)-enriched low-density fractions, but not the T-cell-enriched high-density fractions, showed IFN production by the stimulation of Ge132.

The maximal titer of IFN by NK-enriched fractions (F1 + F2) was observed after a 74-h cultivation in the presence of 200 micrograms/ml Ge132. IFN production by the NK-enriched fractions was abrogated by treatment of the cells with monoclonal antibody against human NK cells in the presence of complement. The treatment with antiserum-neutralizing human IFN-gamma resulted in a marked reduction, indicating that a major part of IFN was IFN-gamma. These results suggested that Ge132 might possess affinity to NK cells, inducing IFN production by NK cells.“^[1]

^[1]Munakata, T., Arai, S., Kuwano, K., Furukawa, M. and Y. Tomita. “Induction of interferon production by natural killer cells by organogermanium compound, Ge132.”
Journal of interferon research. Vol. 7, Issue 1. Feb 1987 (69-76). Online. Accessed: 11 May 2007. (Highlighted text by The Editors).
Available: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?CMD=search&DB=pubmed PMID: 3108417 [PubMed - indexed for MEDLINE]

[Inhibitive effects of spirulina on aberrant crypts in colon induced by dimethylhydrazine]

[Article in Chinese]

Summary: GE-132 – Study shows protective ability on Colon Aberrant Cysts.

“Precancerous pathological changes of colon was induced by single injection in a short-term and multiple injection in a long-term intraperitoneally with 1,2-dimethylhydrazine (DMH) in NIH mice and Sprague-Dawley rats. And, protective effects of spirulina, germanium-132 and vitamin E on colon aberrant crypts induced by DMH were observed.

Results showed either single injection or multiple injection with DMH could induce aberrant crypts in colon. The number of aberrant crypts scattered by short-term single injection was less than that by multiple one, and less of the aberrant crypts foci were formed by short-term single injection.

Spirulina powder, germanium-132 and vitamin E all could inhibit the function of aberrant crypts of colon. In the ninth week during multiple injection with DMH, a lot of aberrant crypts of colon had been induced, and a certain amount of aberrant crypts foci had been generated. The number of aberrant crypts and aberrant crypts foci in the animals with tumor increased with the length of DMH injection. In the ninth-, 13th- and 16th-week, respectively, the number of aberrant crypts and aberrant crypts foci was significantly less in animals protected by spirulina than in positive controls (P < 0.01), but there was no significant difference between them during 21st- and 24th-week of injections.”^[1]

Hengyang Medical College
Hengyang Hunan.

^[1]Chen, F. and Q. Zhang. “[Inhibitive effects of spirulina on aberrant crypts in colon induced by dimethylhydrazine].” (Article in Chinese).
Zhonghua yu fang yi xue za zhi. (Chinese journal of preventive medicine). Vol. 29, Issue 1. Jan 1995 (13-7). Online. Accessed: 11 May 2007. (Highlighted text by The Editors).
Available: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?CMD=search&DB=pubmed PMID: 7600882 [PubMed - indexed for MEDLINE]

[An observation of antiproliferative effect of germanium-132 on cultured pterygium fibroblasts]

[Article in Chinese]

Summary: GE-132 – Study shows effect on Pterygium Fibroblasts.

“OBJECTIVE: To detect the antiproliferation of carboxyethyl germanium sesquioxide (Ge-132) on fibroblasts of pterygium in vitro and try to find a potentially effective agent for treatment of primary pterygium and prevention of its postoperative recurrence.

METHODS: Primary culture and subculture of pterygium fibroblasts were established in vitro. Different concentrations of Ge-132 (39 – 5,000 mg/L) or mitomycin-C (3.13 – 4.00 mg/L, the control) were added to the fibroblast culture of the third or forth passage respectively. The inhibitory effect was determined by MTT (tetrazolium bromide) method. The influence of addition of Ge-132 on the growth curve of fibroblasts was observed, and the changing expression of proliferating cell nuclear antigen (PCNA) in fibroblasts was studied by immunohistochemical method

RESULTS: The addition of Ge-132 in the culture caused significant inhibition of the fibroblast proliferation in dose dependent manner (625 – 50,000 mg/L) without cytotoxicity (IC(50) = 3,000 mg/L), the marked descent of growth curve and suppression of the expression of PCNA in cultured cells (P < 0.01). CONCLUSION: Ge-132 can inhibit the proliferation of pterygium fibroblast in vitro significantly.“^[1]

Beijing Institute of Ophthalmology
Beijing 100005, China.

^[1]Liu, Y., Sun, X., Li, B. and J. Wang. “[An observation of antiproliferative effect of germanium-132 on cultured pterygium fibroblasts]” (Article in Chinese).
[Zhonghua yan ke za zhi]. (Chinese journal of ophthalmology). Vol. 36, Issue 4. Jul 2000 (263-6), 16. Online. Accessed: 11 May 2007. (Highlighted text by The Editors).
Available: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?CMD=search&DB=pubmed PMID: 11853609 [PubMed - indexed for MEDLINE]

Effect of germanium-132 on low-density lipoprotein oxidation and atherosclerosis in Kurosawa and Kusanagi hypercholesterolemic rabbits.

Summary: GE-132 – Study shows Antioxidant Ability of Germanium-132.

“Germanium-132 (Ge-132) was given at 200 mg/kg of body weight to 8-week-old Kurosawa and Kusanagi hypercholesterolemic (KHC) rabbits. Thirty-six weeks later, the susceptibility of plasma low-density lipoprotein to oxidation and the morphology of atherosclerosis in the aorta and coronary artery were investigated. Treatment with Ge-132 resulted in decreases in the oxidation rate and in the formation rate of thiobarbituric acid-reactive substances following copper-induced oxidation of LDL. Ge-132 is suggested to possess antioxidative properties, but this did not lead to any attenuation of atherosclerotic progression in the KHC rabbits.“^[1]

Department of Medicine, University of Kitasato Medical School
Sagamihara, Japan.
yasiwaka@med.kitasato-u.ac.jp

^[1]Wakabayashi Y. “Effect of germanium-132 on low-density lipoprotein oxidation and atherosclerosis in Kurosawa and Kusanagi hypercholesterolemic rabbits.”
Bioscience, biotechnology, and biochemistry. Vol. 65, Issue 8. Aug 2001 (1893-6). Online. Accessed: 11 May 2007. (Highlighted text by The Editors).
Available: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?CMD=search&DB=pubmed PMID: 11577738 [PubMed - indexed for MEDLINE]

[ Read More ]

The makers of Oxy-Powder® receive questions from time to time regarding the safety and efficacy of the Germanium-132 used in the formulation of this proven colon cleansing health supplement. There has been much confusion about the differences between inorganic Germanium (an element) and Germanium-132 (an oxygen-rich organic compound that is SAFE for human consumption).

In the past, some disreputable manufacturers have formulated their products with cheap imported Ge-132 that was contaminated with inferior grades and even unsafe forms of the substance (such as the poisonous germanium dioxide). Unfortunately, this focus on profit rather than integrity and safety led to several people becoming quite ill and a few reported deaths. The industrial forms of inorganic germanium are potentially toxic and are not sold as nutritional supplements.

With such tragedies in mind, Global Healing Center is providing the following certification concerning the origin of the Germanium-132 used in our products. We receive all of our Ge-132 from Designed Nutritional Products, Inc. and the information provided below is their guarantee that all Ge-132 supplied to its clients is 100% “Made in the U.S.A.” and thus free of contaminants, excipients, and other harmful pollutants.

Even in acute toxicity studies, no animal has died or displayed any external symptoms or internal changes while receiving organic Ge-132. In doses up to 5 times higher than the suggested human dosage, even small mammals such as rabbits suffer no ill side effects nor birth defects in pregnant individuals. No life-threatening side effects have been reported to date in humans. Ge-132 has been studied for its antiviral, immuno-stimulatory, and free-radical scavenging actions, and especially for supporting oxygen utilization in plants and animals.

Global Healing Center and Oxypowder.com assert absolutely no imported or inferior grade Germanium-132 is used in Oxy-Powder® and that all organic compounds and minerals used in our products undergo the strictest quality controls and processing before meeting our standards. For example, every batch of our Germanium-132 is assayed for composition and purity. With Oxy-Powder® you receive the safest and most effective colon cleansing supplement on the market. Guaranteed!

Designed Nutritional Products, Inc. hereby warrants and certifies:

1. That it owns the manufacturing process technology by which Bis (2-carboxethylgermanium-sesquioxide), commonly called germanium sesquioxide, which it sells, is produced.
2. That germanium sesquioxide has been produced in the State of Utah, U.S.A., since 1987 using the process technology which it owns.
3. That the germanium sesquioxide, which it sells, has been and is produced using the process technology which it owns.
4. That the germanium sesquioxide, which it sells, qualifies for and fulfills “Made in the U.S.A.” standards for wholesale and retail labeling.
5. That the germanium sesquioxide, which it sells, is produced under strict process controls to stringent specifications in accordance with recognized process controls and standards.
6. That the purity and quality of the germanium sesquioxide which it sells has been and is verified through independent third party testing laboratories. Summary compilations of those laboratory reports are provided with each product shipment. Actual test reports are available to individual customers upon a showing of need and specific request.

[ Read More ]

Citric acid is an organic acid but not to be confused with Vitamin C, which is ascorbic acid. Despite this minor point of misunderstanding, citric acid is found in many citrus fruits: pineapples, gooseberries, limes, plums, lemons, peaches, oranges, and grapefruit.

Carl Wilhelm Scheele first isolated citric acid from a lemon in 1784 utilizing the fungus Aspergillus niger. Scheele had an odd habit of actually tasting various substances as he “discovered” them and it’s easy to see how this could be detrimental to one’s health, as he went on to independently isolate “. . . barium (1774), chlorine (1774), manganese (1774), molybdenum (1778), and tungsten (1781), as well as several chemical compounds, including citric acid, glycerol, hydrogen cyanide . . . hydrogen fluoride, and hydrogen sulfide.” ¹

Citric acid is helpful for the body because:

• Helps prevent urinary tract infections
• Can be used as a natural preservative in lieu of chemicals
• Facilitates energy production within cells [as explained below]
• A great natural astringent (instead of alcohol)
• Helps regulate pH in the digestive tract
• Promotes efficient digestive function
• Aids in the removal of toxins from the body
• Prevents dysentery, diarrhea, and other bowel diseases
• Helps breakdown fatty foods and increases appetite

Interestingly, citric acid in a slightly modified form (Potassium citrate) can suspend the human heartbeat for greater facility during surgery and is also being applied successfully to leach harmful metals from the soil in landfills. Nearly ¾ of all citric acid produced in the United States is used in consumable products (foods and beverages), while the remaining portion is employed for the manufacturing of household detergents and various industrial applications.

Regarding its health benefits, citric acid is normally referenced as a byproduct of the Citric Acid Cycle (also known as the Krebs cycle) which is one of the three types of cellular respiration in human metabolism. Without the Citric Acid Cycle, we would be literally power-less with no energy for running, studying, playing, working, exercising or whatever you need to do. Read on!

The Citric Acid Cycle Explained:

1. Eating gets it going

Whenever you consume anything (but especially fats, carbs, and sugars), the food must be converted into a basic form of energy within the mitochondria so our bodies can make use of them. Food is metabolized into acetyl groups consisting of 2 atoms of carbon, 1 atom of oxygen, plus 1 atom of hydrogen. Acetyl groups combine with 4-carbon oxaloacetate molecules to produce the 6-carbon citric acid molecules.

2. Breathing adds oxygen to the fire

Citric acid is covalent which means it readily shares its electrons with other molecules. Two of its carbon atoms are used to create carbon dioxide (a waste product of human respiration) while 4 remaining electrons are freed to form ATP (adenosine triphosphate), Creatine phosphate, and Guanosinetriphosphate, all of which are basically energy molecules for the body to power its various chemical processes.

3. The perpetual engine of metabolism

Along the way, ATP combines with oxygen to form water—perhaps the most essential element of all. Amazingly, one of the final results of the Citric Acid Cycle is the production of a new oxaloacetate molecule. In theory, your body can harvest energy from food unceasingly as long as you keep eating and supplying fresh water to keep cells healthy and functional.

4. Interference

Of course, cells can become damaged by any number of environmental factors, poor dietary habits, and lifestyle choices, including:

• Smoking
• Consuming alcohol (a poison), junk food, and processed foods
• Taking drugs of any kind (including medications)
• Exposing yourself to pollution, smog, or toxic water and soil
• Too much or too little sunlight
• Not exercising on a regular basis
• Not staying hydrated by drinking purified water
• Radiation from electromagnetic sources (televisions, old CRT computer monitors, microwaves, and especially cellphones)

Many factors of a modern, highly industrialized lifestyle contribute to the incidence of disease, a lessening of overall health quality, and especially to impaired digestive function. Besides the prevalence of chemical toxins in our natural environments, any processed foods you eat likely contain a variety of pesticides, artificial flavoring agents and preservatives, fillers, unnecessary additives, unfiltered minerals, and even intentional modifications (such as fluoride in drinking water). All of these non-natural substances function as just extra toxins for the body to remove.

This is why it’s so important to consume only organic foods such as raw vegetables, fresh fruit, and purified water. Your colon creates mucous as a defensive measure to these harmful foods. Over time, the mucous can build up to such a degree your colon becomes impacted, constricted, or weakened and thus physiologically impaired and then you can no longer absorb enough nutrients from your food to maintain proper health.

Clinical studies have demonstrated the efficacy of using oxygen based colon cleansers over traditional remedies such as laxatives or enemas. Colon cleansing with oxygen not only helps to eliminate impacted waste matter, but this method oxygenates internal organs and the bloodstream as well.

Citric acid helps to facilitate the production and subsequent delivery of oxygen and is thus a valuable component of Oxy-Powder®. In addition, as described above, the inclusion of citric acid leads to increased production of ADP and ATP and we could all certainly benefit from having more energy.

Actually, the Citric Acid Cycle cannot occur without the presence of oxygen because this element is vital for the transport and “sharing” of electrons, which in turn leads to the production of energy for the entire body. It’s easy to see how increasing the level of ambient oxygen is great for streamlining metabolic function and optimizing general health. Therefore, organic citric acid is a perfect choice for complementing the other amazing ingredients of Oxy-Powder®!

¹ Wikipedia. “Carl Wilhelm Scheele.” Online. Modified: 8 Mar 2

[ Read More ]

The name “magnesium” stems from the Greek word Magnesia, so named as a reference to the geographic region where the substance was first discovered. This is where the term “milk of Magnesia” comes from, but this substance is actually magnesium hydroxide which is a type of saline laxative. Elemental magnesium, on the other hand, is the eighth most abundant item on the Periodic Table and the fourth most abundant mineral in the human body.

Dietary magnesium is obtained primarily from natural sources such as mineral springs, wells, and seas. Because of its healing properties, magnesium is marketed in many health supplements as a dietary antacid or sometimes as a laxative. The Scottish physicist Joseph Black first isolated magnesium in 1755.¹

Types of Magnesium

Magnesium Hydroxide – Mg(OH)₂

Magnesium hydroxide, as stated above, is the scientific term for milk of Magnesia which is often prescribed as a laxative. The hydroxyl compound really just pulls salts from the blood into the intestines. This saline fluid performs a flushing effect within the intestines so you can have a bowel movement, but in the process you are losing important salts from the body and this can lead to an electrolyte deficiency.

Magnesium Sulfate – MgSO₄

Magnesium sulphate is otherwise known as Epsom salt and is commonly used as a “home remedy” laxative. Ingesting Epsom salts does not produce as many side effects as drinking milk of Magnesia but it also does little to rid the bowel of hard compacted fecal matter. Furthermore, Epsom salts do not provide monatomic oxygen to the bowel, which aids in your body’s natural healing process.

Magnesium Oxide – MgO

Oxy-Powder® contains a unique formulation of ozonated magnesium oxide, magnesium hydroxide, and ozonated magnesium peroxide, which are not dietary forms of magnesium per se’ but work as vectors to provide nascent oxygen to your body’s various internal systems and organs.

In our Analysis of Oxy-Powder® and Competitors’ Products, clinical tests demonstrated Oxy-Powder® can produce beneficial oxygen for breaking up fecal matter and also for oxygenating the entire intestinal tract at effective levels for over 18 hours.

This durability stems in part from the magnesium oxides’ ability to transport the oxygen being produced in your digestive system by the organic Germanium-132 and Citric Acid as well as other oxygen you receive by swallowing while eating/drinking and while breathing. Magnesium oxide is basic (meaning, non-acidic) and will have an antacid effect if consumed in amounts above 500 mg. Therefore, drinking organic goat’s milk (a more healthful substitute for dairy milk) to provide Vitamin D can also increase the bio-availability of MgO in the body.

In clinical tests utilizing iodiometric titration, Oxy-Powder® produced a pH around 4.0 (slightly acidic) which results from the inclusion of citric acid to aid in the oxygenation process. The presence of various forms of magnesium oxides could be observed due to the “cloudiness” of the test solutions.

This phenomenon continued over the entire 18-hour test period, so one may easily infer Oxy-Powder® continued to produce measurable amounts of oxygen. Relating to the health benefit thereof, eighteen hours of continuous oxidative function means Oxy-Powder® will work very effectively at breaking down accumulated waste matter within the digestive tract for an extended period.

Factors Affecting Bowel Function

• Age
• Exercise and sleep patterns
• Poor diet (consuming fatty, salty, artificially preserved, and/or chemical-heavy junk foods)
• Neurogenic disorders (nerve function problems)
• Consumption of iron supplements
• Drug use (pain killers, anti-depressants, heart medications, antihistamines, and other prescription drugs)
• Habitual dehydration
• Low levels of thyroid hormone
• Kidney impairment or failure
• Other disorders (Diabetes, IBS, etc.)

Any of these individual factors or a combination of them can damage the nerve cells in the intestinal lining and this can lead to persistent or occasional constipation. This occurs because the nerve function can continue to degrade until you become virtually unable to have a bowel movement on your own.

Around this time, people start resorting to unscientific or even dangerous methods to relieve themselves, such as taking harmful herbal laxatives, subjecting themselves to constant enemas, consuming large amounts of prunes or prune juice, or even spending hard-earned money on water colonics and other invasive procedures.

Why Must I Constantly Replace Magnesium?

Magnesium is also lost naturally through the body’s eliminatory processes of sweating and having bowel movements. Obviously, any increase in physical activity will speed up this process with the additional demands placed on the body by engaging in strenuous exercise, working in the yard on a hot summer day, or stress from taking a difficult exam.

It is extremely difficult to obtain enough dietary magnesium through eating foods alone since it is lost through modern refinement methods. For example, the processing of flour to make white bread removes most of the dietary magnesium.

Replenishing this essential mineral is vital for maintaining the body’s physiological functions, so it must be obtained regularly by eating as much organic foods (such as raw vegetables, fresh fruits, and especially nuts and berries) or by taking a dietary supplement.

Furthermore, when the digestive process is already hindered by a digestive problem (such as IBS, chronic constipation, diarrhea, or Crohn’s Disease) magnesium absorption can fall to levels far below its RDA.

How Does Magnesium Work in Oxy-Powder®?

Although the different variations and compounds of magnesium act in different ways, the magnesium oxides in Oxy-Powder® is as a carrier of oxygen. Through the presence of a proprietary blend of magnesium oxides in Oxy-Powder®, oxygen can be safely and continuously delivered throughout the entire intestinal tract for many hours.

Oxy-Powder® provides relief for constipation symptoms gradually and effectively rather than all at once such as you would experience with a stimulant laxative or chemical enema. Also, while the food you eat is being moved along the entire digestive system, the ingredients in Oxy-Powder® go along for the ride.

While your food is being carried along by bowel contractions, the magnesium oxides carry the monatomic oxygen being released by the citric acid. Oxygen is thereby available throughout the digestive tract to be absorbed and utilized.

Germanium-132 is an oxygen donor as well so the magnesium oxides can receive additional oxygen for delivery into your digestive system. It has been demonstrated that reception of large amounts of oxygen helps alleviate discomfort associated with a the symptoms of a wide array of negative health conditions.

Basically, oxygen is delivered by the ingredients of Oxy-Powder® in a steady and continuous manner so the whole of your intestines (including the colon) can be thoroughly purged of accumulated toxin-laden waste, undigested food, and other organic debris. Also, anything that aids oxygenation is beneficial for all your organs and metabolism to work their best!

¹ Wikipedia. “Magnesium.” Online. Modified: 18 Mar 2007. Accessed: 19 Mar 2007.
Available: http://en.wikipedia.org/wiki/Magnesium

[ Read More ]

A Marketing and Export Letter certifies a substance has been clearly labeled, packaged, and declared for export to other countries providing it meets the laws of those destinations and is not intended for direct resale. Although the Food and Drug Administration is charged with product safety, the Department of Health and Human Services has determined that Organic Germanium-132 can be freely marketed and sold within the United States and other countries if these additional requirements are maintained. In other words, Ge-132 has not been “banned” or prohibited for use in a nutritional supplement.

View the Markting and Export Letter

[ Read More ]

How does Oxy-Powder® Release Nascent/Monatomic Oxygen?

Is It Really Monoatomic?

As early as 1845, reference to nascent oxygen – then speculated to be monoatomic oxygen – first appeared in the technical literature. The references were found in discussions regarding the discovery of ozone, some five years earlier by the German chemist Christian Schonbein. At that time, the molecular structure of ozone was yet unknown. In 1924, the first reference thought to be the first actual identification of a monoatomic form of oxygen was found and labeled “nascent” oxygen. This term came from the Latin nasci or nascentum, meaning to be born – the connotation being that this oxygen form was “newly born.”

As new and better analytical methods were developed, our understandings of the highly reactive oxygen forms became more precise and the nomenclature was changed to reflect the new information. The term “nascent” shifted back to “monoatomic” and was later modified to “monatomic”, and is now most often referred to categorically as “singlet” oxygen. The latter term has more to do with the configuration of the electrons than to the atomic or molecular configuration itself. In popular literature, all of the above terms can be found. Singlet oxygen is now identified as being any of many highly reactive forms of oxygen, both monatomic and diatomic.

From 1978 to the most recent review, 143 U.S. Patents were issued using the term monatomic oxygen in the text. During the same time period the term monoatomic oxygen was used in 78 issued patents. The term nascent oxygen appeared in 418 patents while singlet oxygen appeared in 2655, and Reactive Oxygen Species appeared in 2203. In most cases, the patents were for production methods of high-energy forms of oxygen, while others were for methods to protect against the oxidants. As one can see, the term monoatomic has become least popular in the technical world, even though its usage continues in the popular press and literature directed toward the lay market.

In biochemistry, the term singlet has often given way to the term “Reactive Oxygen Species” (ROS). ROS has been further broadened to include such oxidizers as hypochlorous acid (HClO), hardly a oxygen specie, by strict definition. So now throughout the technical and popular world, we have a confusion of terms – nascent, monoatomic, monatomic, singlet and reactive oxygen species. It is beyond difficult to select a suitable term that will be understandable and acceptable to everyone at all academic levels. Is the now archaic term “nascent” a safe term to use? What about ROS?

The term ROS in the field of nutrition carries with it negative connotations. ROS are credited with damaging the mitochondrial DNA leading to premature aging and disease, as well as having other deleterious affects. The nutrition industry expends a substantial amount of money and energy marketing products designed to protect against evil ROS, without regard for the fact that that our immune system relies on ROS to destroy bacteria and viruses. Even the facultative Probiotic bacteria such as acidophilus, secrete hydrogen peroxide, much to the benefit of the colon. It matters little that many metabolic functions use ROS in one form or another, in the normal state of affairs. In spite of the fact that ROS are essential in many metabolic functions, the negative connotations prevail. Therefore, without regard for scientific fact, it is apparent that we should not use the term ROS in describing our product due to its negative connotations.

Today we have much scientific evidence that monatomic oxygen species exist everywhere around us, not just in outer space. These species are found with a variety of electron configurations. The literature describes five known forms and several other forms that are postulated on empirical data.

The known monatomic species include the oxygen atom:

• in its first ground state (3P)
• in its first excited state (1D)
• in its second excited state (1S)
• as the oxygen cation (O+)
• as the oxygen anion (O-)

Another group of postulated monatomic species include oxene (‑O-) in its various allotropic forms. At last literature search, these and other species were yet to be fully quantified. However, there is sufficient data to strongly suggest oxene participation in metal-organic reactions, including the reactions in the catalytic cycle of cytochrome P-450 and in other biological systems as well.

The rate at which these ROS are produced is dependent upon several factors. These include but are not limited to, pH, temperature, degree of hydration, presence of transition metals, type of organic materials present, and concentration and type of antioxidants present.

There is now vast literature identifying the various allotropic and electron configurations of oxygen. Several international academic institutions host special conferences devoted to this subject.

Moscow State University, Russia, is one of the leading institutions studying reactive oxygen species and their varying atomic and molecular structures in living systems. We anxiously await each new information release as their research on singlet oxygen and other ROS continues.

Away from the living systems – more akin to the physics of space – we have the following cited research along with subsequent research conducted by Carolyn Aita, University of Wisconsin-Milwaukee and Michel Marhic, Northwestern University, Evanston, Illinois (now at Swansea University in Wales):

Journal of Vacuum Science & Technology A: Vacuum, Surfaces, and Films — January 1983 — Volume 1, Issue 1, pp. 69-73

Optical emission from neon/oxygen rf sputtering glow discharges

C. R. Aita, Materials Department and the Laboratory for Surface Studies, University of Wisconsin–Milwaukee, Milwaukee, Wisconsin 53201

M. E. Marhic, Department of Electrical Engineering and Computer Science, Northwestern University, Evanston, Illinois 60201

The results of an optical emission study of neon and oxygen species which exist in Ne/O2 rf diode sputtering glow discharges are presented. Comparing emission intensities in pure Ne and Ne/O2 mixtures at constant total gas pressure, it was found that the addition of O2 to the sputtering gas quenches Ne i emission and increases emission from O i and O2+ species to a greater extent than that which would be expected from the relative changes in neon and oxygen concentrations, respectively. Although this effect could be caused by a change in the electron density and electron energy distribution function, the correlation between Ne i, O i, and O2+ emission suggests that metastable neon atoms may interact directly with ground state diatomic oxygen molecules in two competing ways: (1) by Penning ionization which produces O2+ and (2) by a quasiresonant transfer of excitation which leads to the production of O. The results are compared to those previously obtained for Ar/O2 discharges using identical sputtering conditions, where the dominant interaction between the rare gas and O2 leads entirely to the production of monatomic oxygen.

How do you attach or stabilize this “Oxygen” in the production of Oxy-Powder®?

With the assistance of such distinguished researchers as Aita, Marhic, and others, our knowledge base has greatly expanded. Many process modifications and refinements have resulted, but there are many factors that remain constant. We are unable to answer all technical inquiries in detail, as that would compromise the security of the proprietary methodologies employed in the production of our product. However, general descriptions of the technology can be discussed.

The initial reaction in our process takes place with the employment of corona discharge plasma. Variables include amplitude, oscillation frequency, waveform, capacitance, temperature, pressure, flow rate, selection of catalyst and inert gas composition and ratios. Oscillation frequencies approaching 200,000 Hz with electrical fields from 80,000 to 120,000 volts are typical in the production of the ultra-high energy oxygen forms using corona discharge plasma (Certain types of ozone generators use a rather primitive version of corona discharge). Variations in voltage, capacitance and oscillation frequency affect concentration and also can affect the electromotive strength of the singlet forms through differences in electron pairing and ionization. Waveform and inert gas involvement affects structure while temperature affects stability. Pressure, flow rate and type of catalyst affect production rates. Although conditions within the plasma are not identical to the conditions believed to exist in the heliopause and in the lower exosphere – well above our atmosphere, where monatomic and various other singlet oxygen species are formed – the end results are similar.

The most difficult aspect of the process comes during the attachment of the highly reactive oxygen species to metallic compounds, while simultaneously achieving the necessary levels of stability. We have been successful in attaching various reactive oxygen species to aluminum, barium, calcium, lithium, magnesium and titanium. Most singlet forms have a lifespan measured in nanoseconds to milliseconds, making predictable and controllable attachment problematic. The attachment portion of the process must remain proprietary.

In order for the final product to deliver a slow, steady supply of oxidant over an extended time period, it is necessary to provide a predictable and controllable destabilizing mechanism. In this case, it is the hydrogen ion from a source delivered with a limited degree of ionization. The selection of citric acid as the destabilizer provides a limited yet compatible degree of ionization, sufficient to affect slow destabilization over several hours. Once the destabilization has occurred, the resulting singlet form is short-lived, delivering its energy to any available acceptor.

Regarding the reported antioxidant action of citric acid, rather than being a direct antioxidant, citric acid inhibits the catalytic action of transition metal compounds, such as Fe+++ and Cu++, from catalyzing the formation of ROS in biochemical systems. In the absence of transition metals, citric acid has little or no antioxidant properties.

[ Read More ]

Summary

“The clinical trial has been conducted following Globally accepted Regulatory Guidelines and practices as follows”:

• Human clinical trial was conducted following “Good Clinical Practices (GCP)” under supervision of an expert team following Helsinki’s Declaration for protection of rights of the patients.The entire study was conducted based on globally accepted ICH 6E guidelines for determining Safety, Efficacy and Tolerability of Oxy-Powder® in Human subjects.
• The Animal toxicity studies were conducted in an ISO certified laboratory following WHO GCP guidelines and as per OECD tests.
• The capsules can be safely consumed by all vegetarians and non-vegetarians alike The ingredients, including the outer inactive cover (Kosher Shell) are Vegetarian. None of the non-vegetarian materials such as gelatin, egg product, meat or chicken products, sea food products, non-vegetarian oils and fats have been employed in the formulation or during processing.

Constipation is the slow movement of feces (stool or body wastes) through the large intestine resulting in infrequent bowel movements and the passage of dry, hard stools. The longer it takes for the stool to move through the large intestine, the more fluid is absorbed and the drier and harder the stool becomes. Constipation is annoying and uncomfortable, but fecal impaction (a collection of dry, hard stool in the colon or rectum) can be life threatening. Patients with a fecal impaction may not have gastrointestinal symptoms. Instead, they may have circulation, heart, or breathing problems. If fecal impaction is not recognized, the signs and symptoms will get worse and the patient could die. Irritable bowel syndrome (IBS), a functional gastrointestinal disorder characterized by the interplay of altered motility, abnormal visceral sensation, and psychosocial factors, is one of the most common reasons for referral to a gastroenterologist. It is associated with bouts of constipation and diarrhea.

Oxy-Powder® used universally as a dietary supplement for relieving constipation was taken up for the study under Clinical Trials Phase III in 40 constipation and 20 IBS patients in Open, Randomized, Comparative studies in 2 Centers. The Study protocol included exclusion and inclusion criteria, mode of administration of test and reference products, evaluation of effectiveness and safety and data analysis and management. The GCP guidelines were followed for the conduct of the studies. Reporting of AEs and SAEs has been emphasized. The duration of the study, post administration was 6 weeks. Primary objective of the clinical trial was to evaluate effectiveness and safety of Oxy-Powder® in treating constipation and IBS.

The final results indicated that complete cure was obtained in 42.3% patients treated with Oxy-Powder® (as against 7.7% with Dulcolax), Improvement in 57.7% in patients treated with Oxy-Powder® (as against 76.9 % with Dulcolax), and 0% failure in patients treated with Oxy-Powder® (as against 15.4 % with Dulcolax), Thus, efficacy of Oxy-Powder® in treating constipation was significantly more than Dulcolax. This indicated that Oxy-Powder® was more efficacious in treating constipation than Dulcolax.

As regards ADR’s in the Constipation group of patients, one patient in Oxy-Powder® administered group of 27 patients had severe diarrhea on the 2nd day of treatment. He could not carry out his usual activities and felt dehydrated; hence he was withdrawn from the study on 3rd day. Out of the remaining 26 patients, 2 patients had abdominal fullness after taking Oxy-Powder® for 2-3 days after which they were symptom- free. Remaining 24 patients had no ADR’s. In the 13 Dulcolax administered group patients, 1 patient had mild abdominal pain which disappeared without medication. Remaining 12 patients had no ADR’s. As regards ADR’s in IBS + Constipation group of patients, none of the patients had any adverse events during the study period.

[ Read More ]

Oxy-Powder®
28-Day Safety Study Sub-Chronic Toxicity Report

PROJECT NO.12204
SUBCHRONIC ORAL TOXICITY STUDY (28 DAY) OF OXY-POWDER®
IN THE SPRAGUE DAWLEY RAT

The Sub-Chronic oral toxicity study was designed and conducted to determine the toxicity profile of Oxy-Powder® when administered daily for 28 days in Sprague Dawley rats. In the acute toxicity test the compound was found to be non toxic at the dose level of 5000 mg/kg body weight. The dose has been selected on this basis and the justification provided on page 14 of this report.

Oxy-Powder® suspended in distilled water was administered to animals at the dose levels 250 mg/kg, 500 mg/kg and 1000 mg/kg body weight. Two additional dose levels were added to the study as 0 mg/kg (Rev.) and 1000 mg/kg (Rev.), in order to study the reversibility or delayed occurrence of symptoms, if any. The control animals were administered with vehicle only.

Salient features of the study were as follows:

1. All the male and female animals from control and all the treated dose groups up to 1000 mg/kg survived throughout the dosing period of 28 days and the recovery period of 14 days.
2. No signs of intoxication were observed in male and female animals from different dose groups during the dosing period of 28 days and during the recovery period of 14 days.
3. Male and female animals from all the treated dose groups exhibited comparable body weight gain with that of controls throughout the dosing period of 28 days and the recovery period of 14 days.
4. Food consumption of control and treated animals was found to be comparable throughout the dosing period of 28 days and the recovery period of 14 days.
5. Ophthalmoscopic examination, conducted prior to and at the end of dosing period on animals from control and all the treated dose groups did not reveal any abnormality.
6. Hematological analysis conducted at the end of the dosing period on day 29 and at the end of recovery period on day 43, revealed no abnormalities attributable to the treatment.
7. Biochemical analysis conducted at the end of the dosing period on day 29 and at the end of recovery period on day 43, revealed no abnormalities attributable to the treatment.
8. Functional battery observation tests conducted at termination revealed no abnormalities.
9. Urine analysis, conducted at the end of the dosing period in week 4 and at the end of recovery period in week 6, revealed no abnormality attributable to the treatment.
10. Organ weight data of male and female sacrificed at the end of the dosing period and at the end of the recovery period was found to be comparable with that of respective controls.
11. Gross pathological examination did not reveal any abnormality.
12. Histopathological examination did not reveal any abnormality.

Based on these findings the no observed effect level (NOEL) of Oxy-Powder® supplied by Mayfair Clinical Education and Research Centre, Mumbai, in Sprague Dawley rat via oral route, over a period of 28 days was found to be 1000 mg/kg body weight for male and female animals.

[ Read More ]

Oxy-Powder®
14-Day Safety Study Acute Toxicity Report

PROJECT NO.12203
ACUTE ORAL TOXICITY OF OXY-POWDER®
IN SPRAGUE DAWLEY RATS

SUMMARY AND CONCLUSION

This study was designed to determine the acute oral toxicity profile of Oxy-Powder® in Sprague Dawley rats. The sighting study did not result in any signs of intoxication at the dose level of 2000 mg/kg body weight and the animal survived; therefore, one animal was treated with the higher dose of 5000 mg/kg body weight. No signs of intoxication were observed in animals treated at the dose level of 5000 mg/kg body weight. Therefore the main study was continued at the dose level of 5000 mg/kg body weight. The main study did not result in any signs of intoxication at the dose level of 5000 mg/kg body weight. All animals survived through the study period of 14 days. Gross pathological examination did not reveal any abnormalities.

It was concluded that the acute toxicity study of Oxy-Powder® supplied by Mayfair Clinical Education and Research Centre, Mumbai, when administered via oral route in Sprague Dawley rats falls into the category 5 criteria of Globally Harmonised System (GHS).

[ Read More ]

Oxy-Powder®
IN-VITRO ANTI-BACTERIAL ACTIVITY TEST

The results very clearly indicate that Oxy-Powder® is ineffective in killing the test cultures in-vitro.

It is very encouraging to see that the Probiotic organisms Lactobacillus bulgaricus is also not killed by Oxy-Powder®. This indicates the survival of Probiotic organisms even when Oxy-Powder® is acting in the large intestine and colon region against constipation. Other normal physiological processes including generation of B complex factors by the Probiotic organisms shall continue in routine and would avoid administration of B complex factors externally to the patients suffering from constipation and undergoing treatment with Oxy-Powder®.

[ Read More ]

This summary report has been extracted from the Original Phase I, II, and III active, controlled Clinical Studies on Oxy-Powder®. We tested many components of Oxy-Powder® including acute toxicity, sub-chronic toxicity and anti-bacterial activity. We also tested the effectiveness of Oxy-Powder® for symptoms of chronic constipation, and IBS (Irritable Bowel Syndrome). For ease of reading, we summarized the results of each test.

Summary of Oxy-Powder® Clinical Study Results for IBS with related constipation.

• None (0%) of the IBS test patients reported any Adverse Reactions to Oxy-Powder® after 6 weeks of use.
• 27 out of 27 (100%) of the IBS test patients had Straining during their Bowel Movements on Day 0 of testing as compared to only 1 of the patients on Day 42.
• 24 out of 27 patients (92.3%) suffering from IBS indicated that Oxy-Powder® was successful in relieving straining during bowel movements.
• 24 out of 27 (92.3%) of the IBS test patients passed hard and lumpy stools during bowel movements on Day 0 whereas on Day 21 and through day 42, none (0%) of the patients passed hard and lumpy stools. This indicated a 100% success rate for Oxy-Powder® in relieving symptoms of hard and lumpy stools within 21 days.
• 27 out of 27 (100%) of the IBS test patients had Sensation of Incomplete Evacuation during their bowel movements on Day 0 of testing, which was reduced to only 6 out of 27 (23.1%) of the patients on Day 42.
• 20 out of 27 (76.9%) patients suffering from IBS indicated that Oxy-Powder® was successful in relieving sensations of incomplete evacuation during bowel movements.
• 10 out of 27 (38.5%) of the IBS test patients had Sensation of Anorectic Blockage during bowel movements on Day 0 whereas on Day 21 and through day 42, none of the patients (0%) had sensation of anorectic blockage. This indicated a 100% success rate for Oxy-Powder® in relieving sensations of anorectic blockage within 21 days in patients suffering from IBS.
• 10 out of 27 (30.8%) IBS test patients had to perform Manual Maneuvers to Facilitate their Bowel Movements on Day 0 whereas on Day 21 and through day 42, none (0%) of the patients had to perform manual maneuvers. This indicated a 100% success rate for Oxy-Powder® in relieving manual maneuvers to facilitate bowel movements within 21 days.
• 20 out of 27 (76.9%) IBS test patients had Abdominal Pain associated with a change in frequency of Stools on Day 0. On Day 21, only 4 out of 27 (15.4%) patients had abdominal pain and on Day 42, none of the (0%) patients had Abdominal Pain associated with a change in frequency of stools. This indicated a 100% success rate for Oxy-Powder® in relieving abdominal pain associated with a change in frequency of stools after 42 days.
• 14 out of 27 (53.8%) of the IBS test patients had Abdominal Pain associated with a change in form of stools on Day 0. On Day 21, only 2 out of 27 (7.7%) patients had abdominal pain and on Day 42, none of the patients (0%) patients had abdominal pain associated with a change in form of stools. This indicated a 100% success rate for Oxy-Powder® in relieving abdominal pain associated with a change in form of stools after 42 days.
• 6 out of 27 (23.1%) of the IBS test patients Passed Mucous during their Bowel Movement on Day 0, where as by Day 21 and continuing through Day 42, none (0%) of the patients passed mucous during their bowel movement. This indicated a 100% success rate for Oxy-Powder® in relieving mucous during bowel movements within 21 days.
• 22 out of 27 (84.6%) of the IBS test patients had Abdominal Fullness (bloating) on day 0. On Day 21, only 8 out of 27 (30.8%) of the patients had abdominal fullness and on Day 42, only 2 out of 27 (7.7%) of the patients had abdominal fullness (bloating).
• 24 out of 27 (92.3%) indicated that Oxy-Powder® was successful in relieving abdominal fullness (bloating) within 42 days.
• 8 out of 27 (30.8%) of the patients treated with Oxy-Powder® reported a Complete Cure for IBS with related constipation after 6 weeks of testing.
• 18 out of 27 (69.2%) of the patients treated with Oxy-Powder® reported significant Improvement in symptoms of IBS with related constipation after 6 weeks.
• None of the patients (0%) treated with Oxy-Powder® reported failure in treating IBS with Related Constipation after 6 weeks.

“Safety and Efficacy of Oxy-Powder® in treating IBS with constipation was significantly high, thus indicating Oxy-Powder® was both safe and efficacious in treating patients of IBS with constipation”.

NOTE: This trial was restricted to 42 days (6 weeks) to get a success rate of safety and efficacy in an optimum period of use. Individuals are at liberty to modify the duration and dosing as per the guidance of their physician. This is due to the high levels of safety of Oxy-Powder®, experimentally determined in animal toxicity testing in rats as per OECD regulatory guidelines as well as in Patients suffering from IBS with Constipation.

“The clinical trial has been conducted following Globally accepted Regulatory Guidelines and practices as follows”:

• Human clinical trial was conducted following “Good Clinical Practices (GCP)” under supervision of an expert team following Helsinki’s Declaration for protection of rights of the patients.The entire study was conducted based on globally accepted ICH 6E guidelines for determining Safety, Efficacy and Tolerability of Oxy-Powder® in Human subjects.
• The Animal toxicity studies were conducted in an ISO certified laboratory following WHO GCP guidelines and as per OECD tests.
• The capsules can be safely consumed by all vegetarians and non-vegetarians alike The ingredients, including the outer inactive cover (Kosher Shell) are Vegetarian. None of the non-vegetarian materials such as gelatin, egg product, meat or chicken products, sea food products, non-vegetarian oils and fats have been employed in the formulation or during processing.

[ Read More ]

This summary report has been extracted from the Original Phase I, II, and III active, controlled Clinical Studies on Oxy-Powder®. We tested many components of Oxy-Powder® including acute toxicity, sub-chronic toxicity and anti-bacterial activity. We also tested the effectiveness of Oxy-Powder® for symptoms of chronic constipation, and IBS (Irritable Bowel Syndrome). For ease of reading, we summarized the results of each test.

According to the Rome II criteria for constipation, all patients in the study were suffering from constipation for 12 weeks (3 months) or more.

Summary of Oxy-Powder® Clinical Study for Chronic Constipation

• 25 of 27 patients (92.6%) had straining during bowel movements on Day 0 as compared to Day 42 when only 2 (7.7%) patients had this symptom. A significant reduction in symptoms was achieved after administration of Oxy-Powder®.
• 26 of 27 patients (96.3%) passed hard and lumpy stools on Day 0 where as on Day 42 it was reported only in two patients (7.7%). A significant reduction in symptoms was achieved after administration of Oxy-Powder®.
• 25 of 27 patients (92.6%) had sensation of incomplete evacuation on Day 0 where as on Day 42 it was reported only in 5 (19.2%). A significant reduction in symptoms was achieved after administration of Oxy-Powder®.
• 15 of 27 patients (55.6%) had sensation of anorectal blockage on Day 0 where as on Day 42 it was reported only in 1 (3.8%). A significant reduction in symptoms was achieved after administration of Oxy-Powder®.
• 11 of 27 patients (40.7%) had to perform manual maneuvers to facilitate bowel movements on Day 0 where as by Day 21 it was reported that 0 patients had any further symptoms. A significant reduction in symptoms was achieved after administration of Oxy-Powder®.

One patient in the Oxy-Powder® administered group of 27 patients had severe diarrhea on the 2nd day of treatment. He could not carry out his usual activities and felt dehydrated; hence he was withdrawn from the study on 3rd day reducing the study population to 26 patients.

Routine stool examination done before and after the drug treatment showed no abnormality in all patients in this study.

Investigator Summary:
In the group of 26 patients, Investigator assessment was Excellent for 13 (50%), Good for 12 (46.2%), Fair for 1 (3.8 %), and Poor for none (0.0%). Results indicate Oxy-Powder® was effective in treating constipation and reducing the symptoms associated with constipation according to the Rome II Criteria for diagnosing chronic constipation.

Patient Summary:
In the group of 26 completed patients, the Patient assessment was Excellent for 12 (46.2%), Good for 13 (50%), Fair for 1 (3.8%), and Poor for none (0.0%). Results indicate Oxy-Powder® was effective in treating constipation and reducing the symptoms associated with constipation according to the Rome II Criteria for diagnosing chronic constipation.

Overall Efficacy was also judged as Complete Cure, Improvement, and Failure. Table 14 shows that in Group A (out of 26 patients), 11 patients (42.3%) had Complete Cure, 15 patients (57.7%) had Improvement, and there was no Failure.

The final results indicated:

Complete cure: 42.3% patients treated with Oxy-Powder®.

Significant Improvement: 57.7% in patients treated with Oxy-Powder®.

Failure: 0% in patients treated with Oxy-Powder®.

Thus, efficacy of Oxy-Powder® in treating constipation was significant. This indicated Oxy-Powder® was efficacious in treating constipation.

Results Above Indicate Efficacy of Oxy-Powder® is Significant in Treating Patients of Constipation.

“The clinical trial has been conducted following Globally accepted Regulatory Guidelines and practices as follows”:

• Human clinical trial was conducted following “Good Clinical Practices (GCP)” under supervision of an expert team following Helsinki’s Declaration for protection of rights of the patients.The entire study was conducted based on globally accepted ICH 6E guidelines for determining Safety, Efficacy and Tolerability of Oxy-Powder® in Human subjects.
• The Animal toxicity studies were conducted in an ISO certified laboratory following WHO GCP guidelines and as per OECD tests.
• The capsules can be safely consumed by all vegetarians and non-vegetarians alike The ingredients, including the outer inactive cover (Kosher Shell) are Vegetarian. None of the non-vegetarian materials such as gelatin, egg product, meat or chicken products, sea food products, non-vegetarian oils and fats have been employed in the formulation or during processing.

[ Read More ]