CTRI/2023/03/051094
Not yet recruiting
Phase 2
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 sites0 target enrollmentTBD
ConditionsHealth Condition 1: K590- Constipation
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: K590- Constipation
- Sponsor
- upin Limited
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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