A Double Blind, Placebo-Controlled, Randomized, Crossover Study To Evaluate The Effectiveness, Safety And Tolerability Of Porelis On Weight Management In Overweight Subjects.

Vidya Herbs Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年3月4日

试验速览

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•1.Overweight Subject: BMI = 25.00 to < 30 kg/m2
•2.Subject willing to adhere with their routine diet and exercise regimen throughout the study.
•3.Females of childbearing age, who agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening.
•4. Must be willing and able to give informed consent and comply with the study procedures.

•1.Subjects suffering from intractable obesity, had defined weight limits, or had experienced any recent,unexplained weight loss or gain six months prior to screening.
•2.Pathophysiologic/genetic syndromes associated with obesity (Cushing’s syndrome, Turner’s
•syndrome, Prader–Willi syndrome).
•3.Intake of over the counterweight loss agents, centrally acting appetite suppressants in the previous six months
•4.Subjects suffering from any chronic health conditions (e.g., diabetes, hypertension, chronic renal failure, heart, thyroid, and liver disease).
•5.Subjects allergic to herbal products or any component of the study product.
•6. Known HIV or Hepatitis B positive or any other immuno-compromised state.
•7. History of
•-Chronic metabolic disease
•-Psychiatric illness.
•-Drug abuse, smoking, abuse/addiction to alcohol
•-Bariatric surgery
•-Eating disorder such as bulimia or binge eating
•-Endocrine abnormalities including stable thyroid disease.
•-Cardiovascular surgery
•-History of any major surgery
•8.Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study.
•9.Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.

发起方