Health Condition 1: K582- Mixed irritable bowel syndrome
Conditions
Interventions
Intervention1: Drug Name - Kutajavaleha: Drug Name - Kutajavaleha (API part II, Vol IV)
Dosage form - Avaleha (Semisolid/paste form)
Dose - 10 gm. twice daily before food orally with luke warm water.
Sponsors
Central Council for Research in Ayurvedic Sciences New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1.Known cases of Grahani roga (diagnostic criteria as per classical Ayurvedic Parameters) 2. Patient willing to give written informed consent for participation in the study.
Exclusion criteria
Exclusion criteria: 1.Patients with history of Inflammatory bowel diseases (IBD), Abdominal Koch,Gluten Intolerance. 2.Patients with history of Chronic amoebiasis. 3.Known cases of Diabetes mellitus. 4.Patients with poorly controlled Hypertension ( >160/100 mmHg). 5.Patients who have history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months. 6.Symptomatic patients with clinical evidence of Heart failure. 7.Known cases of malignancy. 8.Patients with concurrent serious hepatic disorders (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT) > 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). 9.Women who are planning for conception / pregnant or lactating. 10.H/o hypersensitivity to any of the trial drugs or their ingredients 11. Patients who have completed participation in any other clinical trial during the past three months. 12.Any other condition which the Investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the clinical efficacy of Kutajavaleha by the assessment of Changes observed in Grahani Severity Questionnarie score based on its Ayurveda symptomatologyTimepoint: [Time Frame: Baseline (0 week); 2 week, 4 week, 6 week, 8 week, 10 week, 12 week (treatment period); and at 14 week (post treatment follow up period)] | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the clinical efficacy of Kutajavaleha by the assessment of Changes observed in IBS-QOL score.Timepoint: [Time Frame: Baseline (0 week); 2 week, 4 week, 6 week, 8 week, 10 week, 12 week (treatment period); and at 14 week (post treatment follow up period)] | — |
Countries
India
Contacts
Public ContactDr Choudhary Kuldeep Rattaram
Regional Ayurveda Research Institute for Gastrointestinal Disorders,Guwahati
Outcome results
None listed