EFFECT OF DIET THERAPY AND VYOSHADI SAKTU IN REDUCING OBESITY- A COMPARATIVE STUDY
- Conditions
- Health Condition 1: null- Obese, Non DM, Non HT
- Registration Number
- CTRI/2015/11/006333
- Lead Sponsor
- Government Ayurveda Medical college Mysore
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
•Elevated levels of lipid profile
•BMI between >30 to 40kg/m2
•Willing to come for regular follow-up visits
•Able to give written information consent
•Intake of over the counter weight loss agents, centrally acting appetite suppressants in the previous six months
•Pathophysiological/ genetic syndromes associated with obesity (Cushingâ??s syndrome, Turnerâ??s syndrome, Prader willi syndrome)
•Patients with evidence of malignancy
•Patients with poorly controlled Diabetes Mellitus (HbA1c > 10%)
•Patients with poorly controlled Hypertension ( >160/100 mm Hg)
•Patients on prolonged ( > 6 weeks) medication with corticosteroids, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study
•Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Tuberculosis, Psycho-Neuro-Endocrinal disorders etc.)
•Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infraction, Stroke or Severe Arrhythmia in the last 6 months
•Symptomatic patient with clinical evidence of Heart failure.
•Patients with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) > 2.5 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.
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•History of HIV and other viral infections
•Alcoholics and/or drug abusers
•Prior surgical therapy for obesity
•History of hypersensitivity to any of the herbal extracts or dietary supplements.
•Pregnant/ lactating women.
•Patients who have completed participation in any other clinical trial during the past six (03) months.
•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 Decrease in body weight and body mass index <br/ ><br>Decrease in waist circumference and waist hip ratio (anthropometric measurements) <br/ ><br>Timepoint: 30 days
- Secondary Outcome Measures
Name Time Method Decrease in cholesterol, Triglycerides, LDL and VLDL values from baseline <br/ ><br>Increase in HDL values from baseline <br/ ><br>Increase in the levels of serum calcium and BMD <br/ ><br>Timepoint: 30 days