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 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年1月22日

试验速览

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•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.
•(The Rome 4 diagnostic criteria for Functional constipation, 2016)

•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.
•6. Subjects with uncontrolled DM and hypertension and Tuberculosis.
•7. Known cases of HIV, tuberculosis, hypo and hyperthyroidism
•8. Known cases of renal or liver dysfunction.
•9. Subjects diagnosed with neurological problems like,
•a). Parkinson’s disease
•b). Multiple sclerosis
•c). Sacral nerve damage (prior pelvic surgery, tumor)
•d). Paraplegia
•e). Autonomic neuropathy
•10. Subjects on chronic medication (greater than 60 days) and or who are on medications known to cause constipation.
•11. Pregnant or lactating females
•12. Subjects allergic or atopic to any of the ingredients of the study medications
•13. Other conditions, which in the opinion of the investigators makes the patient unsuitable for enrolment or could interfere in adherence to of the study protocol.

发起方

SANDOOK SUTRAS PVT LTD