A Prospective, Randomized, Double blind, Placebo controlled clinical trial to evaluate efficacy and safety of Slimferin tablets in reducing the bodyweight in obese patients.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Vidya herbs
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- •Reduction in body weight and BMI
Study Overview
Brief Summary
A Prospective, Randomized, Double blind, Placebo controlled clinical trial to evaluate efficacy and safety of Slimferin tablets in reducing the bodyweight in obese patients.
The drug which is been used in the study is a composition of an herbal product called Mangifera Indica. Mangifera Indica is a Mango Peel Extract. The extract contains good amount of pharmacologically active flavonoid, a natural xanthone C-glycoside
Primary objectives:
· To evaluate the safety and efficacy of Slimferin for treating obesity in obese patients
Secondary objectives:
· To evaluate the safety and role of Slimferin in improving the quality of life of the subjects
Primary outcomes
- Reduction in body weight and BMI (Baseline, Week 2, Week 4 and Week 8)
Secondary outcomes
-
Changes in lipid profile (Baseline and Week 8)
-
Changes in anthropometric measurements-Waist circumference and waist to hip ratio reduction.
-
Quality of life of the subjects (SF-36) before and after.
-
Random blood Glucose and Hb1Ac concentration (Baseline and Week 56)
-
Incidence and rate of adverse events
-
Selected Laboratory Investigations (Hematology & Biochemistry) at baseline and week 8.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 50.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •â€¢Age between 18 and 50 years.
- •â€¢Able to sign voluntarily informed consent.
- •â€¢Obese subjects with Body mass index 30 to 40 kg/m2 •Subjects must understand risks and benefits of the protocol •Willingness to participate in the exercise walking program •If female, should be negative in pregnancy test.
- •Female of child bearing potential, should agree to follow an acceptable method of birth control for the duration of the study.
Exclusion Criteria
- •â€¢Have a history of major problems such as heart disease, thyroid disease or diabetes in the last five years.
- •â€¢Presently using other weight loss medications, as well as stimulants, laxatives or diuretics taken solely for the purpose of weight loss •Recent, unexplained weight loss or gain •History of HIV positive patients •History of hepatitis, pancreatitis, lactic acidosis or hepatomegaly with steatosis.
- •â€¢History of motor weakness or peripheral sensory neuropathy •Have orthopedic joint problems that would be barrier to physical activity such as walking.
- •â€¢Are currently participating in any weight loss clinical trial.
- •â€¢Women who are pregnant and nursing mothers •People with major psychiatric illness •Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
Outcomes
Primary Outcomes
•Reduction in body weight and BMI
Time Frame: At Baseline, week 2, 4 and week 8
Secondary Outcomes
- •Changes in lipid profile (Baseline and Week 8)(•Changes in anthropometric measurements-Waist circumference and waist to hip ratio reduction.)