Health Condition 1: null- Obese, Non DM, Non HTN
Conditions
Interventions
Intervention1: Vyoshdi sakthu: its an Drug Forulation is in the Use in ayurveda for managing Obesity.
Control Intervention1: Diet Therapy: Diet of the patient is regulated
Sponsors
Government Ayurveda Medical college Mysore
Eligibility
Inclusion criteria
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
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 (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. . • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decrease in body weight and body mass index Decrease in waist circumference and waist hip ratio (anthropometric measurements) Timepoint: 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 Timepoint: 30 days | — |
Countries
India
Contacts
Public ContactDr Anand Katti
Govt. Ayurveda Medical college,
Outcome results
None listed