This is a study to evaluate the efficacy and safety of SlimilynÂ® Capsules verses placebo in overweight and obese adult subjects.

Completed

Brief Summary: Overweight and obesity are growing health problems all over the world. It is a direct result of food-intake in excess of body energy expenditure. An alternative strategy for the induction of increased energy expenditure is via the activation of thermogenic cells that utilize fat to produce heat with the help of herbal supplements. It is a safe and cost-effective method of weight reduction for many overweight and obese individuals.

Slimilyn consists of various herbal extracts in combination with minerals and amino acids. As per pre-clinical and clinical studies reported earlier, it was found to be safe for consumption. It has been postulated, Slimilyn helps in the management of weight loss. This is a double blind, randomized, placebo controlled clinical trial for

the evaluation of weight loss, safety, and tolerability of SlimilynÂ® in overweight and obese volunteers.

Recruitment & Eligibility

Inclusion Criteria

Adult males and non-pregnant females aged 18 to 60 years.
Have a BMI of 25.0 kg/m2and above, along with body fat of >25%.
Stable body weight during the previous 3 months (less than 5 kg self-reported weight change) d.
Not one of the following eating disorders by subjects declaration anorexia nervosa, bulimia nervosa.
Generally considered healthy according to medical history, physical examination, electrocardiogram (ECG), and laboratory evaluation with a special emphasis on metabolic parameters (fasting glucose concentration < 100 mg, normal blood pressure) as per principal investigatorâ€™s judgment.
Subjects must be able to adhere to the visit schedule and protocol requirements and be available to complete the study.
Subjects must sign an informed consent indicating that they are aware of the investigational nature of the study.

Exclusion Criteria

Diagnosis of type 1 or type 2 diabetes b.
Visit 1 thyroid-stimulating hormone (TSH) outside of the range of 0.4- 4.5 Î¼IU/mL c.
History of chronic pancreatitis or idiopathic acute pancreatitis and other chronic gastroenterological disease d.
Obesity induced by other endocrinologic disorders (e.g., Cushing Syndrome) e.
Current or history of treatment with medications that may cause significant weight gain for at least 3 months before this trial f.
Current participation in an organized diet reduction program (or within the last 3 months) g.
Previous surgical treatment for obesity (excluding liposuction if performed more than one year before trial) h.
Subjects on prescription and non-prescription appetite or weight modifying drugs including herbal products i.
Used of any investigational drug or device during the study or within 30 days prior to 1st dosing of study.

Primary Outcome Measures

Name	Time	Method
Change in body weight from baseline to end of the treatment (Day 90) (along with the percentage of participants who achieve a minimum of 10% weight loss	day 0 to day 90

Secondary Outcome Measures

Name	Time	Method
â€¢ Change in Body Fat, Waist Circumference and Body Mass Index (BMI) From	Baseline to end of the treatment (Day 90)

Locations (1): Narayana Super Speciality Hospitals
🇮🇳
Bangalore, KARNATAKA, India
Narayana Super Speciality Hospitals
🇮🇳Bangalore, KARNATAKA, India
DR MEGHANA MURTHY
Principal investigator
7259214727
meggydoc@gmail.com