Ayurvedic study for the treatment of Obesity
- Conditions
- Health Condition 1: null- Obesity
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Patients of either sex with age above 25years and below 60 years.
2.Obese patient having 20% excess weight than desirable weight according to height, sex and age / age adjusted BMI above 85th percentile (Indian standard)
3.WHR- Waist Hip circumference Ratio > 0.95 in males & > 0.8 in females.
1.Age below 25 years and above 60 years
2.Obesity secondary to or associated with Hypothyroidism, Hyper tension, Diabetes mellitus, Hyperlipidemia or Cushingâ??s syndrome.
3.Pregnancy and lactation.
4.Patients who cannot report in person once in 2 weeks in the OPD
5.Patients with poorly controlled Hypertension ( >160/100 mmHg)
6.Patients with poorly controlled Diabetes Mellitus having Hb A1C of > 8
7.Patients who have a past history of Arterial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
8.Symptomatic patient with clinical evidence of Heart failure.
9.Known HIV & Viral Hepatitis positive cases
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, smokers, and/or drug abusers
12.H/o hypersensitivity to any of the trial drugs or their ingredients
13.Patients who have completed participation in any other clinical trial during the past six months.
14.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 Obesity in EOSS (Edmonton obesity scoring system) <br/ ><br> <br/ ><br>Timepoint: Total Study Period-2 years <br/ ><br>Preparation-3 months <br/ ><br>Recruitment-18 months <br/ ><br>Statistical Analysis-3 months <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method Waist Hip Circumference <br/ ><br>BMI <br/ ><br>Changes in SymptomsTimepoint: Treatment period - 12 weeks <br/ ><br>Follow up 2 weeks