Health Condition 1: null- Obesity (Sthaulya)
Conditions
Interventions
Intervention1: Vyoshadi Guggulu: Dose â?? 1.5 gm (3 Tablets)twice daily
Dosage form - Tablet of 500 mg
Route of Administration â?? oral
Time of Administration-Twice a day before food
Anupana-Lukewarm
Sponsors
Department of AYUSH Ministry of Health Family Welfare Government of India
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either sex with age between 18 and 65 years. 2. BMI >=30 kg/m2 and 3. Willing and able to participate in the study for 16 weeks.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| · 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
| Measure | Time frame |
|---|---|
| · Change in waist circumference and waist: hip ratio. · Change in Lipid Profile. · 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. 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. | — |
Countries
India
Contacts
Public ContactDr Pradeep Dua
Central Council for Research in Ayurvedic Sciences (CCRAS)
Outcome results
None listed