Health Condition 1: E663- Overweight
Conditions
Interventions
Intervention1: Slimferin Tablets-Twice daily
: Composition
Mangifera Indica extract tablets, Twice daily for 2 months taken orally
Control Intervention1: Placebo: Twice daily taken orally
Sponsors
Vidya herbs
Eligibility
Inclusion criteria
Inclusion criteria: • Age between 18 and 50 years. • Able to sign voluntarily informed consent. • 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
Exclusion criteria: • Have a history of major problems such as heart disease, thyroid disease or diabetes in the last five years. • Any other clinically significant disorder • Abnormal fibrinogen levels • Non-obese (BMI 40). • 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. • History of motor weakness or peripheral sensory neuropathy • Have orthopedic joint problems that would be barrier to physical activity such as walking. • Are currently participating in any weight loss clinical trial. • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ Reduction in body weight and BMITimepoint: At Baseline, week 2, 4 and week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Changes in lipid profile (Baseline and Week 8) â?¢ Changes in anthropometric measurements-Waist circumference and waist to hip ratio reduction. â?¢ Quality of life of the subjects (SF-36) before and after. â?¢ Random blood Glucose and Hb1Ac concentration (Baseline and Week 56) â?¢ Incidence and rate of adverse events â?¢ Selected Laboratory Investigations (Hematology & Biochemistry) at baseline and week 8. Timepoint: At baseline and week 8 | — |
Countries
India
Contacts
Public ContactDr Harisha S
ICBio Clinical research Pvt Ltd
Outcome results
None listed