A study to investigate the effect of Brihat Gangadhar Churna in the treatment of Irritable bowel syndrome

Phase 2

• Conditions: Health Condition 1: null- Irritable Bowel Syndrome

• Registration Number: CTRI/2016/01/006550
• Lead Sponsor: Central Council for Research in Ayurvedic Sciences CCRAS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 90

Inclusion Criteria

1. Known case of IBS as per Rome III criteria :

(Symptoms of recurrent abdominal pain or discomfort and a marked change in bowel habit for at least six months, with symptoms experienced on at least 3 days/month in the last 3 months associated with two or more of the following:

Pain is relieved by defecation

Onset associated with change of frequency of stools (Constipation: < 3 - week, diarrhoea > 3/days

Onset associated with a change in form (Bristol Stool chart

Type 1-2 constipation, Type 6-7 diarrhea.

2. Willing and able to participate in the study for 14 weeks.

Exclusion Criteria

1. Patients with bleeding per rectum.

2. Mixed infection with parasites like round worms, hook worms etc.

3. Patients with evidence of malignancy

4. Patients with Diabetes Mellitus {B.S. (F) > 126 mg% and / or B.S. (2 hr. PP) >200 mg%

5. Patient with poorly controlled Hypertension ( > 160 / 100 mm Hg)

6. Patients on prolonged ( > 6 weeks) medication with corticosteoids, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study.

7. Patients suffering from any systemic illness affecting the bowel habits as assessed by PI.

8. Patients having history of unstable cardiovascular disease.

9. Patients with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) > 2 times upper normal limit) or Renal Disorders (defined as S. Creatinine >1.4mg/dL), Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]), or any other condition that may jeopardize the study.

11. Alcoholics and/or drug abusers.

12. H/o hypersensitivity to the trial drug or any of its ingredients.

13. Pregnant / lactating woman.

14. Patients who have completed participation in any other clinical trial during the past six (06) months.

15. Any other condition which the Principal Investigator thinks may jeopardize the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Global Improvement in signs and symptoms of IBSTimepoint: At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up after 14th week.

Secondary Outcome Measures

Name	Time	Method
Proportion of patients who achieve improvement in Diarrhoea /Constipation.Timepoint: At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up after 14th week.