Clinical Efficacy and Safety of Brihat Gangadhara Churna in the Management of Irritable Bowel Syndrome (IBS)

Central Council for Research in Ayurvedic Sciences CCRAS0 个研究点目标入组 90 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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.

•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.

发起方

Central Council for Research in Ayurvedic Sciences CCRAS