Jatiphaladi Churna and Chitrakadi Gutika in the treatment of Grahani (Irritable bowel Syndrome)
- Conditions
- Health Condition 1: K582- Mixed irritable bowel syndrome
- Registration Number
- CTRI/2019/08/020607
- Lead Sponsor
- CCRASNew Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Patients of either sex aged 18-65 years
2.Known cases of Grahani (diagnostic criteria as per classical Ayurvedic Parameters) with following symptoms
3.Patients willing to give written informed consent and able to participate for 3 months.
1.Patients with history of Inflammatory Bowel Disease (IBD), Kochâ??s Abdomen, 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the clinical efficacy of Jatiphaladya Churna & Chitrakadi Gutika by the assessment of Changes in Ayurvedic Parameters of Grahani <br/ ><br> <br/ ><br>Timepoint: Base line , At the end of 14th day, 28th day, 42nd day, 56th day, and 70th day, 84th day and 98th day. <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method To assess the clinical efficacy of Jatiphaladya Churna & Chitrakadi Gutika by the assessment of Changes in IBS-QOL scoreTimepoint: Base line , At the end of 14th day, 28th day, 42nd day, 56th day, and 70th day, 84th day and 98th day. <br/ ><br> <br/ ><br>