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

Obesity is a condition in which a person has excess body fat. More than just a number on a scale or the size of someone’s body, obesity can increase a person’s risk of diseases and health problems, including high blood pressure, diabetes and heart disease. It is a complex problem and major public health concerns. Obesity is usually defines using a ratio of height to weight called body mass index (BMI), which often correlates with the person’s level of body fat. According to the CDC BMI of 30.0 Kg/m2 or higher is considered as obese.

Currently, plant-based natural products as anti-obesity therapeutics are largely unexplored. Many plant-derived molecules have been found to possess anti-obesity effects with advantages over chemical treatments. So there is a basic need to develop effective drugs for obesity management/treatment with minimal side effects. Plants may prove promising options for the same.Natural plant products are widely used in healthcare or as dietary supplements. The important phytomolecules include flavonoids, terpenoids, saponins, phenols and alkaloids. The majority of plant extracts are not single compounds but rather a mixture of different molecules; therefore their mechanism of action usually targets several organ and cellular systems. The phytomolecules would act through their inhibitory activities for pancreatic lipases, adipocyte differentiation or by increasing thermogenesis and anorexia. In this review, we discuss the anti-obesity potential of phytomolecules and also analyze their mechanisms for treating obesity.

STUDY RATIONALE

Obinil Tab:

Obinil Tab is a unique combination of several nutritional supplements, which decreases the cholesterol level and also blood pressure. It works by preventing some of the fat in foods eaten from being absorbed in the intestines. This unabsorbed fat is then removed from the body in the stool.

Total of 120 subjects will be enrolled in the study and randomized into two groups, one group receiving Obinil tablets as a dietary supplements and other group receiving placebo [2 tablets twice a day after meals]. The individual subject participation will be for 90 days, additional 15 days for follow up.

Safety End Points: Laboratory investigations will be performed to check abnormal lab parameters. Lab investigations will include; a) CBC b) Biochemistry c) Urine examination All adverse events (AEs) and SAE will be recorded at each visit to assess safety of the IP. Systemic Examinations: Physical examination (performed on all visits i.e., screening and all follow-up visits) Pulse rate, Respiratory rate, temperature, systolic and diastolic blood pressure Systemic examinations will be performed on all the visits and the clinical abnormality shall be noted in CRF. The quality of life questionnaires will be checked and body mass index, anthropometric measurements like 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 will be recorded. Urine pregnancy test will be performed for all females who have not reach menopause will undergo urine pregnancy test in local lab. After satisfying all eligibility criteria, investigator will perform detailed physical and systemic examination and will give patient a test request form for laboratory investigations. Based on these investigations, investigator will decide whether the subject is eligible to participate in the clinical trial study.