Health Condition 1: Z682- Body mass index (BMI) 20-29, adult
Conditions
Interventions
Intervention1: Obinil: Obinil or Placebo are tablets with multiple ingredients. Treatment will be allocated as per randomization code list. Eligible subjects have to consume two tablets of obinil or
Sponsors
SAVA Healthcare Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male &/ Or female volunteers aged between 18 to 65 years both inclusive. 2. BMI greater than or equal to 25 kg/m2 and less than or equal to 34.9 Kg/m2. 3. willing to exercise for a span of 30 min daily for at lease 5 days in a week.4. willing to follow diet advised by investigator. 5. willing to come for regular follow up visits.
Exclusion criteria
Exclusion criteria: Intake of over the counter weight loss agents, centrally acting appetite suppressants or prior surgery for obesity in the previous three months. 2. History of pathophysiologic/ genetic syndromes associated with obesity (Cushingâ??s syndrome, Turnerâ??s syndrome, Parder-Willi syndrome). 3. Alcoholics and subjects with substance abuse. 4. Subjects with evidence of malignancy. 5. Subjects having history of underlying inflammatory arthropathy, septic arthritis, inflammatory joint disease, gout, pseudo gout, Pagetâ??s disease, joint fracture, acromegaly, fibromyalgia, rheumatoid arthritis. 6. Subjects having history of coagulopathies, cardiovascular diseases, Asthma. 7. Subjects with HbAlc > 7% and poorly controlled diabetes mellitus, poorly controlled hypertension. 8. TSH > 10mIU/L and T3 and T4 higher than normal range. 9. Pregnant and lactating women. 10. Subjects with hepatic and renal failure. 11. Subjects 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. 12. Subjects with hypersensitivity to any one ingredient of the drugs. 13. Subjects who have participated in other trial within last 3 months. 14. Any other condition which the principal investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate efficacy of Anti-obesity Formulated Tab Obinil in obese subjects by assessingTimepoint: Change in body weight over the period of 90 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate efficacy of Anti-obesity Formulated Tab Obinil in obese subjects by assessingTimepoint: Change in body weight (kg) over a period of 3 months of treatment between the groups. 2. Change in anthropometric measurements (waist circumference, hip circumference, waist: hip ratio, body fat percentage, basal metabolic rate (BMR), total body water (TBW), lean body mass (LBM), neck circumference, upper mid arm circumference, calf circumference) between the groups. 3. Change in serum leptin level between the groups. 4. Change in lipid profile between the groups. | — |
Countries
India
Contacts
Public ContactMr Chandu Devanpally
SAVA Healthcare Ltd
Outcome results
None listed