Health Condition 1: null- Irritable Bowel Syndrome
Conditions
Interventions
Intervention1: Bilvadi Leha: Dose â?? 10 gm twice daily
Dosage form - Avleha-
Route of Administration â?? Oral
Time of Administration-Twice a day after food
Anupana-Lukewarm
Water
Packing form- 300
Sponsors
Department of AYUSH Ministry of Health Family Welfare Government of India
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either sex with age between 18 and 65 years 2. Known case of IBS as per Rome III criteria : (Symptoms of recurrent abdominal pain or discomfort and a marked change in bowel habit for atleast six months, with symptoms experienced on atleast 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 frequencey of stools · Onset assoicated with a change in form (appearance) of stools. (Diagnosis to be confirmed by using the IBS module questionnaire) 3. Willing and able to participate in the study
Exclusion criteria
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% OR HbA1c > 6.5%}. 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 major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Tuberculosis, Psycho-Neuro-Endocrinal disorders, etc.) 8. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months. 9. Symptomatic patient with clinical evidence of Heart failure. 10. 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 >1.2mg/dL), Severe 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Global Improvement in signs and symptoms of IBS (IBS severity score) Timepoint: At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up after 16th week. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 16th week. | — |
Countries
India
Contacts
Public ContactDr Pradeep Dua
Central Council for Research in Ayurvedic Sciences (CCRAS)
Outcome results
None listed