Health Condition 1: E00-E89- Endocrine, nutritional and metabolic diseases Health Condition 2: null- Patients of either gender with age between 20 and 45 years with 30 kg/m2 â?¥BMI 40 kg/m2
Conditions
Interventions
Intervention1: Naagarmotha churna: The powdered drug will be administered at a dose of 3 gm thrice a day orally before food with luke warm water for 12 weeks.
Control Intervention1: Extract of Garcini
Sponsors
All India Institute of Ayurveda
Eligibility
Inclusion criteria
Inclusion criteria: Patients with BMI equal and more than 30 or less than 40 will be registered.
Exclusion criteria
Exclusion criteria: I.Intake of over the counter weight loss agents, centrally acting appetite suppressants in the previous six months. II.Pathophysiologic/ genetic syndromes associated with obesity (Cushingâ??s syndrome, Turnerâ??s syndrome, Praderwilli syndrome). III.Patients with evidence of malignancy IV.Patients with poorly controlled Diabetes Mellitus (HbA1c > 10%) V.Patients with poorly controlled Hypertension ( > 160 / 100 mm Hg) VI.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. VII.Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Tuberculosis, Psycho-Neuro-Endocrinal disorders, etc.) IX. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months. IX.Symptomatic patient with clinical evidence of Heart failure. X.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. XI.Alcoholics and/or drug abusers. XII.Prior surgical therapy for obesity XIII.H/o hypersensitivity to any of the trial drugs or their ingredients. XIV.Pregnant / lactating woman. XV.Patients who have completed participation in any other clinical trial during the past six (06) months. XVI.Any other condition which the Principal Investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight lossTimepoint: The patients will be assessed at the end of 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in BMI Change in waist circumference and waist hip ratio. Change in Lipid profile Change in quality of life- SF-36 scale Timepoint: 4 Months | — |
Countries
India
Contacts
Public ContactDr Shikha chaudhary
All India institute of Ayurveda
Outcome results
None listed