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A CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF GREEN SLIM IN PATIENTS WITH OBESITY, DIABETES AND HIGH CHOLESTEROL

Completed
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
Inclusion Criteria

•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.

Exclusion Criteria
  • •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
NameTimeMethod
Primary outcomesAt Screening ,day 112
•Reduction in body weight and BMI, from Baseline to End of treatmentAt Screening ,day 112
•Changes in lipid profile, blood glucose levels & HbA1CAt Screening ,day 112
•Changes in Waist circumference (anthropometric measurements)At Screening ,day 112
•Changes in CRP, Cortisol & Liver enzymes.At Screening ,day 112
Secondary outcomesAt Screening ,day 112
•Changes in body fat percentage and lean muscle/body mass percentageAt Screening ,day 112
•Safety and Tolerability assessed by Adverse EventsAt Screening ,day 112
•Subject QOL questionnaireAt Screening ,day 112
Secondary Outcome Measures
NameTimeMethod
Secondary outcomes•Safety and Tolerability assessed by Adverse Events

Trial Locations

Locations (1)

ANASUYA AYURVEDIC CLINIC

🇮🇳

Bangalore, KARNATAKA, India

ANASUYA AYURVEDIC CLINIC
🇮🇳Bangalore, KARNATAKA, India
Dr K Venkateshwarlu BAMS MD Ayurveda
Principal investigator
9945232107
drvenkatesh64@gmail.com

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