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A clinical study to evaluate the efficacy and safety of Investigational Product on overweight subjects.

A 12-week, randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of GGE03 on overweight subjects.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/03/024216
Enrollment
80
Registered
2020-03-24
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: E663- Overweight

Interventions

Sponsors

GENECELL co ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Volunteers of either sex, between 18 to 60 years of age. 2. Volunteers of a body mass index (BMI), between 25.00 kg/m2 to 29.99 kg/m2 3. Subjects who agree the participation in the trial and submit informed and consent before the beginning of the trial

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Clinically significant positive change from baseline to EOT (End of treatment) in the following efficacy parameters: 1. Body fat rate by DEXA (Dual-energy X-ray absorptiometry) 2. Body fat amount by DEXA (Dual-energy X-ray absorptiometry) Timepoint: 12 weeks

Secondary

MeasureTime frame
1. Weight 2. Waist Circumference 3. Hip Circumference 4. Waist to Hip Ratio 5. Body Mass Index (BMI) 6. Lean Mass by DEXA (Dual-energy X-ray absorptiometry) 7. Total Cholesterol 8. HDL-Cholesterol 9. LDL-Cholesterol 10. Triglyceride 11. Visceral Fat Area 12. Subcutaneous Fat Area 13. Total Fat Area Timepoint: 12 weeks

Countries

India

Contacts

Public ContactSubham Dutta

Syncorp Clincare Technologies Pvt Ltd

anam@syncorp.in

Outcome results

None listed

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