A CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF GREEN SLIM IN PATIENTS WITH OBESITY, DIABETES AND HIGH CHOLESTEROL
- Conditions
- Overweight, obesity and other hyperalimentation,
- Registration Number
- CTRI/2014/05/004635
- Lead Sponsor
- Green Chem
- Brief Summary
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|A Prospective, Randomized, Double blind, Placebo controlled, clinical Study to evaluate the Efficacy and Safety of **GREENSLIM** inpatients withObesity,Diabetes and High Cholesterol
**Primary outcomes**
· Reduction in body weight and BMI, from Baseline to End of treatment
· Changes in lipid profile, blood glucose levels & HbA1C
· Changes in Waist circumference (anthropometric measurements)
· Changes in CRP, Cortisol & Liver enzymes.
· Changes in body fat percentage and lean muscle/body mass percentage
**Secondary outcomes**
· Safety and Tolerability assessed by Adverse Events,Subject QOL questionnaire
**Drug Composition**
Green Slim which contains CARALLUMA FIMBRIATA
**List of excipients**
The key constituents of Caralluma fimbriata are pregnaneglycosides, saponin glycosides, and bitter principles
Extract Solvents Used: Ethylalcohol
Excipients: 10% Maltodextrinmaximum
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
•Male and female subjects aged 18 to 60 years •Obese subjects with Body mass index 25 to 35 kg/m2 •Diabetic subjects with HbA1C ≥ 7% •Moderately elevated Total serum cholesterol level •Subjects must understand risks and benefits of the protocol and be able to give informed consent along with audio video visual •Females of child-bearing potential must agree to use an approved form of birth control and to have a negative pregnancy test result.
- •Any other clinically significant disorder •Have a history of hypertension, Angina, stroke, thyroid diseases •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 •Are currently participating in any clinical trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcomes At Screening ,day 112 •Reduction in body weight and BMI, from Baseline to End of treatment At Screening ,day 112 •Changes in lipid profile, blood glucose levels & HbA1C At Screening ,day 112 •Changes in Waist circumference (anthropometric measurements) At Screening ,day 112 •Changes in CRP, Cortisol & Liver enzymes. At Screening ,day 112 Secondary outcomes At Screening ,day 112 •Changes in body fat percentage and lean muscle/body mass percentage At Screening ,day 112 •Safety and Tolerability assessed by Adverse Events At Screening ,day 112 •Subject QOL questionnaire At Screening ,day 112
- Secondary Outcome Measures
Name Time Method Secondary outcomes •Safety and Tolerability assessed by Adverse Events
Trial Locations
- Locations (1)
ANASUYA AYURVEDIC CLINIC
🇮🇳Bangalore, KARNATAKA, India
ANASUYA AYURVEDIC CLINIC🇮🇳Bangalore, KARNATAKA, IndiaDr K Venkateshwarlu BAMS MD AyurvedaPrincipal investigator9945232107drvenkatesh64@gmail.com