CTRI/2015/01/005349
Completed
Phase 3
A Clinical study to evaluate efficacy and safety of Ayulax Capsule in the Management of Functional Constipation - NI
Welex Laboratories Pvt Ltd0 sites36 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Functional Constipation
- Sponsor
- Welex Laboratories Pvt Ltd
- Enrollment
- 36
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Subjects presenting with two or more of the following for the last 3 months with symptom onset at least 6 months prior to diagnosis
- •a. Straining during at least 25 percent of defecations
- •b. Lumpy or hard stools at least 25 percent of defecations
- •c. Sensation of incomplete evacuation at least 25 percent of defecations
- •d. Sensation of anorectal blockage at least 25 percent of defecations
- •e. Manual maneuvers to facilitate at least 25 percent of defecations
- •f. Fewer than three defecations per week
- •2\. Subjects having stool form between 1 to 3 on the Bristol Stool Form Scale
Exclusion Criteria
- •1\. Subjects with diagnosed colonic inertia.
- •2\. Subjects who have recently undergone abdominal surgery
- •3\. Subjects with history of anorectal surgery.
- •4\. Subjects having other functional gastrointestinal disorders other than Functional constipation (i.e. IBS, Belching disorders etc.)
- •5\. Subjects with serious uncontrolled \& diagnosed systemic ailments like HIV, DM and Tuberculosis.
- •6\. Subjects with renal or liver dysfunction
- •7\. Pregnant or lactating females
- •8\. Subjects with disturbed thyroid functions
Outcomes
Primary Outcomes
Not specified
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