A clinical study to see the effect of some Ayurvedic formulations in the management of Obesity
- Conditions
- Health Condition 1: null- Obesity (Sthaulya)
- Registration Number
- CTRI/2012/01/002377
- Lead Sponsor
- Department of AYUSH Ministry of Health Family Welfare Government of India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 150
1. Patients of either sex with age between 18 and 65 years.
2. BMI >=30 kg/m2 and < 40 kg/m2
3. Willing and able to participate in the study for 16 weeks.
1. Intake of over the counter weight loss agents, centrally acting appetite suppressants in
the previous six months.
2. Pathophysiologic/ genetic syndromes associated with obesity (Cushingâ??s syndrome,
Turnerâ??s syndrome, Prader willi syndrome).
3. Patients with evidence of malignancy
4. Patients with poorly controlled Diabetes Mellitus (HbA1c > 10%)
5. Patients with poorly controlled Hypertension ( > 160 / 100 mm Hg)
6. Patients on prolonged ( > 6 weeks) medication with corticosteoids, antidepressants,
anticholinergics, etc. or any other drugs that may have an influence on the outcome of
the study.
7. Patients suffering from major systemic illness necessitating long term drug treatment
(Rheumatoid arthritis, Tuberculosis, Psycho-Neuro-Endocrinal disorders, etc.)
8. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome,
Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
9. Symptomatic patient with clinical evidence of Heart failure.
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 and/or drug abusers.
12. Prior surgical therapy for obesity
13. H/o hypersensitivity to any of the trial drugs or their ingredients.
14. Pregnant / lactating woman.
15. Patients who have completed participation in any other clinical trial during the past
six (06) months.
16. Any other condition which the Principal Investigator thinks may jeopardize the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method · Change in BMITimepoint: At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up after 16th week.
- Secondary Outcome Measures
Name Time Method · Change in waist circumference and waist: hip ratio. <br/ ><br>· Change in Lipid Profile. <br/ ><br>· Change in quality of life â?? SF-36 ScaleTimepoint: Waist:Hip ratio is done At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end offollow up after 16th week. <br/ ><br>Lipid Profile is done Before and After treatment only wheres as, SF-36 is done at Baseline, at 84th day and after follow up of 16 weeks.