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Active Not RecruitingNCT07083947

Effect of Herbal Compositions on Body Weight, Body Composition and Metabolic Health in Overweight Subjects

A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Effect of Herbal Compositions CL19183 and CL24212 on Body Weight, Body Composition and Metabolic Health in Overweight Subjects

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
150 (actual)
Sponsor
ApexCPG LLC · Industry
Sex
All
Age
22 Years – 55 Years
Healthy volunteers
Accepted

Summary

The Purpose of the study is to evaluate the efficacy of herbal composition CL19183 and CL24212 on body weight, body composition and metabolic health in overweight subjects.

Detailed description

A total of 150 male and female subjects aged between 25 and 55 years will be included in the study. Assessment of inclusion and exclusion criteria will be done based on clinical and laboratory investigations. The eligible subjects will be randomized as per the computer-generated randomization list. The subjects will be assigned to either CL19183:450 mg or CL24212:300 mg or Placebo arm at 1:1:1 ratio. The subjects will be instructed to take one capsule daily in the morning after breakfast for 16 weeks. Apart from primary and secondary outcomes, the study will also record the vital signs and adverse events to evaluate the herbal composition safety and tolerability. The safety assessment of the CL19183 and CL24212 will also include routine laboratory investigations on blood, urine and clinical chemistry at screening and the final visit of the intervention

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTCL19183One capsule taken orally each morning after breakfast with water for 16 weeks
DIETARY_SUPPLEMENTCL24212One capsule taken orally each morning after breakfast with water for 16 weeks
OTHERPlaceboOne capsule taken orally each morning after breakfast with water for 16 weeks

Timeline

Start date
2025-07-16
Primary completion
2026-01-25
Completion
2026-01-25
First posted
2025-07-24
Last updated
2025-12-01

Locations

1 site across 1 country: India

Source: ClinicalTrials.gov record NCT07083947. Inclusion in this directory is not an endorsement.