“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.