Health Condition 1: K581- Irritable bowel syndrome with constipation Health Condition 2: K580- Irritable bowel syndrome with diarrhea Health Condition 3: K582- Mixed irritable bowel syndrome
Conditions
Interventions
Intervention1: Neemint capsules (Each enteric coated capsule contains Neem Oil 350 mg and Peppermint Oil 150 mg): Dose: 2 capsules to be taken on empty stomach each day.
Frequency: Once daily
Route of
Sponsors
NUTRA GRACE
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Gastrointestinal Symptom Rating Scale [GSRS- IBS]Timepoint: Baseline, 1 week, 2 Weeks and 4 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Subjectââ?¬â?¢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 | — |
Countries
India
Contacts
Public ContactMr Sunil Gupta
Pharexcel Consulting
Outcome results
None listed