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

A PROSPECTIVE, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF GREEN SLIM IN PATIENTS WITH OBESITY, DIABETES AND HIGH CHOLESTEROL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/05/004635
Enrollment
30
Registered
2014-05-29
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E65-E68- Overweight, obesity and other hyperalimentation

Interventions

Intervention1: green slim: 4 lozenges a day- two in the morning & two in the night before food for 112 days Control Intervention1: Placebo: 4 lozenges a day- two in the morning & two in the night befo

Sponsors

Green Chem
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Primary outcomes â?¢ Reduction in body weight and BMI, from Baseline to End of treatment â?¢ Changes in lipid profile, blood glucose levels & HbA1C â?¢ Changes in Waist circumference (anthropometric measurements) â?¢ Changes in CRP, Cortisol & Liver enzymes. â?¢ Changes in body fat percentage and lean muscle/body mass percentage Secondary outcomes â?¢ Safety and Tolerability assessed by Adverse Events â?¢ Subject QOL questionnaire Timepoint: At Screening ,day 112—

Secondary

MeasureTime frame
Secondary outcomes â?¢Safety and Tolerability assessed by Adverse Events â?¢Subject QOLTimepoint: At Screening ,day 112—

Countries

India

Contacts

Public ContactDr Harisha S

ICBio Clinical research Pvt Ltd

harish@icbiocro.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026