A Clinical study to evaluate efficacy and safety of Softovac Liquifibre in the Management of Functional Constipation and Irregular Bowel Habit-An Open Label, Randomized, Comparative, Multi centric, Interventional, Prospective, Clinical Study - NI

upin Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年4月3日

试验速览

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•1. Male or female subjects between the age group of 18 to 70 years (Cohort 1) and 6 to 15 years (Cohort 2)
•Subjects diagnosed as per the Rome IV diagnostic criteria for Functional constipation, 2016 (Cohort 1) and ROME IV Criteria for Functional Constipation (H3a) (Cohort 2)
•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.

•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 (i.e., IBS, Belching disorders etc.)
•5. Subjects diagnosed with structural abnormalities of intestine
•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
•10. Subjects on chronic medication ( >60 days) and/or who are on medications known to cause constipation.
•11. Pregnant or lactating females (Cohort 1)
•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

upin Limited