A Randomized, Double Blind, Placebo Controlled, Multicentre, Interventional, Prospective, Clinical Study to Evaluate Efficacy and Safety of Anti-Obesity Formula in Obese Subjects.

SAVA Healthcare Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年3月6日

试验速览

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•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.

•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.

发起方

SAVA Healthcare Ltd