Clinical study of Softovac Liquifibre in constipatio

Phase 2

Conditions: Health Condition 1: K590- Constipation

Registration Number: CTRI/2023/03/051094

Lead Sponsor: upin Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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.

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.