10.22376/ijpbs.2019.10.1.p1-12 Volume 1 Issue 2 2010 (April - June) To conduct a clinical trial for evaluating safety, tolerability and effectiveness of Oxy Powder® (OP) in patients of  lessThan br / greaterThan chronic constipation and Constipation – Predominant IBS. Constipation is the slow movement of feces through  lessThan br / greaterThan the large intestine resulting in the passage of dry, hard stools. Fecal impaction is a collection of dry, hard stool in the  lessThan br / greaterThan colon or rectum. lessThan br / greaterThan Study Design: 6 weeks open, comparative, randomized study enrolling 40 patients of constipation and 20 of IBS.  lessThan br / greaterThan Trial Formulations:  lessThan br / greaterThan (A) Oxy powder ® (Marketed by Global Healing Center, Inc., USA) - Test Product A.  lessThan br / greaterThan (B) Dulcolax Tablets (DX), [manufactured by Zydus Cadila Ltd, (India)] - Reference Product B.  lessThan br / greaterThan Guidelines followed:  lessThan br / greaterThan (a) Rome criteria (b) GCP described under ICH E6 document (c) World Medical Association's (WMA) Bioethics  lessThan br / greaterThan Declaration of Helsinki. (d) Schedule Y in Drugs and Cosmetic Act and (2nd Amendment) Rules, 2005, Ministry of  lessThan br / greaterThan Health and Family Welfare, Government of India, lessThan br / greaterThan End Point(s): lessThan br / greaterThan 1) Recording change in weight 2) The effectiveness of the product for Oxygen delivery in patients  lessThan br / greaterThan 3) Finding of (i) stool examination (ii) Barium Meal X-ray and (iii) Colonoscopy 4) Relief of constipation and IBS.  lessThan br / greaterThan Results and Discussion: There were insignificant changes in weight and blood oxygen levels during treatment in  lessThan br / greaterThan both the Groups. Stool examination did not show abnormality in any patient. Patients in both Groups showed  lessThan br / greaterThan significant reduction in various symptoms including a) straining, (b) passing of lumpy stools(c) sensation of  lessThan br / greaterThan incomplete evacuation & Anorectal Blockage and (e) manual maneuvers to facilitate Bowel movements. lessThan br / greaterThan Overall Efficacy: In Group A, (out of 26), 11 (42.3%) had complete cure, 15 (57.7%) showed Improvement, In  lessThan br / greaterThan Group B, (out of13), 1 (7.7%) had complete cure,10 (76.9%) showed Improvement with 2 (15.9%) failures.  lessThan br / greaterThan Conclusion: lessThan br / greaterThan Safety, Efficacy and tolerability of OP in treating constipation was significantly (P Jogender K. Lalla,Meena U. Shah,Edward III Group GHC’s Oxy Powder®, Dietary supplement vs. Dulcolax– Constipation – Multicentric Clinical Trial – Rome II Criteria – ICH E6 GCP Guidelines– WMA Declaration of Helsinki – Drug Rules Schedule Y (Amendment 2005) -