Health Condition 1: null- Obesity
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Obesity in EOSS (Edmonton obesity scoring system) Timepoint: Total Study Period-2 years Preparation-3 months Recruitment-18 months Statistical Analysis-3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Waist Hip Circumference BMI Changes in SymptomsTimepoint: Treatment period - 12 weeks Follow up 2 weeks | — |
Countries
India
Contacts
Central Council for Research in Ayurvedic Sciences