EFFECT OF DIET THERAPY AND VYOSHADI SAKTU IN REDUCING OBESITY- A COMPARATIVE STUDY

Phase 2

Not yet recruiting

• Conditions: Obese, Non DM, Non HTN

• Registration Number: CTRI/2015/11/006333
• Lead Sponsor: Government Ayurveda Medical college Mysore

Brief Summary

This study is a randomized, parallel group, single-centre  trail comparing the efficacy of diet therapy and Vyoshadi saktu for 30 days in 60 patients with obesity that will be conducted in Govt. ayurveda Medical college, Mysore in India, The primary outcome measures will be Decrease in body weight and body mass index, Decrease in waist circumference and waist hip ratio (anthropometric measurements). The secondary outcomes will Decrease in cholesterol, Triglycerides, LDL and VLDL values from baseline Increase in HDL values from baseline Increase in the levels of serum calcium and BMD

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2015-10-30
• Study Start: 2015-11-27

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

•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.

Exclusion Criteria

• •Intake of over the counter weight loss agents, centrally acting appetite suppressants in the previous six months •Pathophysiological/ genetic syndromes associated with obesity (Cushing’s syndrome, Turner’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.
• •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	30 days
Decrease in waist circumference and waist hip ratio (anthropometric measurements)	30 days

Secondary Outcome Measures

Name	Time	Method
Decrease in cholesterol, Triglycerides, LDL and VLDL values from baseline	Increase in HDL values from baseline

Trial Locations

Locations (1)

Govt. Ayurveda Medical College, ysore; 🇮🇳 Mysore, KARNATAKA, India

Govt. Ayurveda Medical College, ysore

🇮🇳Mysore, KARNATAKA, India

Dr Anand Katti

Principal investigator

9886028646

ayurvedananda@gmail.com