A clinical trial to study the effectiveness and safety of NEEMINT capsules in management of gastrointestinal disorders including Irritable bowel syndrome

Not Applicable

Completed

• Conditions: Health Condition 1: K581- Irritable bowel syndrome with constipationHealth Condition 2: K580- Irritable bowel syndrome with diarrheaHealth Condition 3: K582- Mixed irritable bowel syndrome

• Registration Number: CTRI/2021/04/032735
• Lead Sponsor: TRA GRACE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-04-26
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

1.Subjects in the age group of 18-65 yrs (Inclusive of both genders).

2.Subjects with 2 or more symptoms like indigestion ,abdominal pain or cramps, nausea ,vomiting, bloating, constipation, diarrhoea, changes in bowel habits, loss of appetite.

3.Subjects/legal representative, willing to give a voluntary written informed consent.

4.Subjects should not participate in any other clinical study during participation in the current study

Exclusion Criteria

1.Subjects with any cardiovascular, renal, respiratory or any other chronic illness.

2.Pregnant or lactating females.

3.Allergy to test product.

4.Any subject, in the investigators opinion not considered suitable for enrollment.

5.Subject participating in a similar clinical study, currently or during the previous 90 days

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Gastrointestinal Symptom Rating Scale [GSRS- IBS]Timepoint: Baseline, 1 week, 2 Weeks and 4 Weeks

Secondary Outcome Measures

Name	Time	Method
Change in Subject�s Global Assessment of SymptomsTimepoint: Day 1 to Day 28;IBS- Quality of life questionnaireTimepoint: Baseline, Day 7, Day 14 and Day 28;Monitoring of AE and SAETimepoint: Day 1 to Day 14