CTRI/2023/07/055837
Recruiting
Phase 2
A Clinical study to evaluate efficacy and safety of Amal Tablets in the Management of Functional Constipation and Irregular Bowel Habit-An Open Label, Randomized, Comparative, Multi centric, Interventional, Prospective, Clinical Study - NI
SANDOOK SUTRAS PVT LTD0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- SANDOOK SUTRAS PVT LTD
- Status
- Recruiting
- Last Updated
- 2 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 more than one fourth (25 percentage) of defecations
- •b)Lumpy or hard stools (Bristol Stool Form Scale 1to 2\) more than one fourth (25 percentage) of defecations
- •c)Sensation of incomplete evacuation more than one fourth (25 percentage) of defecations
- •d)Sensation of anorectal obstruction/blockage more than one fourth (25 percentage) of defecations
- •e)Manual manoeuvres to facilitate more than one fourth (25 percentage) of defecations (e.g., digital evacuation, support of the pelvic floor)
- •f)Fewer than three SBM per week
- •g) Loose stools are rarely present without the use of laxatives
- •h)Insufficient criteria for irritable bowel syndrome
- •3\. Subjects who are ready to provide written informed consent and who are ready to willingly participate and follow the protocol requirements of the clinical study.
Exclusion Criteria
- •1\. Subjects diagnosed with 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 (IBS, Belching disorders etc.)
- •5\. Subjects diagnosed with structural abnormalities, like:
- •a). Anorectal: rectal prolapse, rectocele, rectal intussusceptions, anorectal stricture, solitary rectal ulcer syndrome
- •b). Perineal descent
- •c). Colonic or rectal mass or tumor with obstruction example adenocarcinoma
- •d). Colonic stricture: radiation, ischemia, diverticulosis
- •e). Intestinal obstruction.
Outcomes
Primary Outcomes
Not specified
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