Role of certain Ayurvedic Drugs in the Management of Piles.
- Conditions
- Health Condition 1: null- Haemorrhoids (Arsha)
- Registration Number
- CTRI/2014/10/005081
- Lead Sponsor
- Central Council for Research in Ayurvedic Sciences CCRAS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 150
1.Patients of either sex aged 16 â??60 years.
2.Presence of 1st, 2nd & 3rd degree Arsha (Hemorrhoids) confirmed by clinical / proctoscopic / colonoscopic examination (With or without bleeding / painful or painless).
3.Willing and able to participate in the study for 06 weeks
1.Age below 15 years & above 60 years
2.Thrombosed & Strangulated pile mass (Hemorrhoids)
3.Bleeding diathesis
4.Cirrhosis of Liver- Portal hypertension
5.Ulcerative colitis / Crohnâ??s disease
6.Patients with evidence of malignancy
7.Patients on prolonged ( > 6 weeks) medication with corticosteoids, antidepressants, anticholinergics, immunosuppressants, estrogen replacement therapy etc. or any other drugs that may have an influence on the outcome of the study.
8.Patients suffering from major systemic illness necessitating long term drug etc.
9.Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome,
10.Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
11.Symptomatic patient with clinical evidence of Heart failure.
12.Patients having uncontrolled Diabetes Mellitus (Blood Sugar Fasting > 250mg/dl).
13.Patients with concurrent serious hepatic disorder (defined as aspartate aminotransferase (AST) and / or alanine aminotransferase (ALT), total bilirubin or alkaline phosphatase (ALP) > 2 times upper normal limit) or renal disorders (defined as S.creatinine >1.2mg/dL), severe pulmonary dysfunction (uncontrolled asthma and chronic obstructive pulmonary disease [COPD]), inflammatory bowel
14.Disease or any other condition that may jeopardize the study..
15.Pregnant/ lactating females.
16. Patients on oral contraceptives.
17.Alcoholics and/or drug abusers.
18.H/o hypersensitivity to any of the trial drugs or their ingredients.
19.Patients who have completed participation in any other clinical trial during the past six (06) months.
20.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 Reduction in the Pile Mass evident by Inspection / Proctoscopy (Visual perception by physician and Photography)Timepoint: 2 Years
- Secondary Outcome Measures
Name Time Method 1.Control of Bleeding as assessed by physician. <br/ ><br>2.Relief from Constipation (subjective through interrogation) <br/ ><br>3.Improvement in Quality of Life as assessed by SF-36Timepoint: 2 Years