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A clinical study to assess the safety and efficacy of capsifen in a weight management study

A randomised placebo-controlled clinical study to assess the safety and tolerability of Capsifen and its efficacy on energy expenditure

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/04/013157
Enrollment
36
Registered
2018-04-10
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

None listed

Interventions

Intervention1: Capsifen: 200mg capsules once everyday for 56 days Control Intervention1: Placebo: 200mg capsules once everyday for 56 days

Sponsors

Akay Flavours and Aromatics Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Male or female healthy volunteers who have been practicing exercise or training sessions for a minimum period of last 1 month to manage the obesity 2) Age 21-40 Years ( Both Inclusive) 3) Subjects with Body Mass Index (BMI) between 27Kg/m to 40 Kg/m 4) Shall agree to sign an Informed Consent Document

Exclusion criteria

Exclusion criteria: 1) Subject with history of cardiovascular, Type 2 Diabetes mellitus, pulmonary, hepatic, gastrointestinal problems, and renal problems 2) Subjects with a history of anorexia nevosa or other eating disorders 3) Subjects with known history of gastrointestinal irregularities 4) Prior use of anti obesity agents 5) History of surgical therapy for obesity 6) Subjects with known genetical syndromes which cause obesity 7) Subjects who are currently under any kind of long term medication 8) Subjects with a known allergy to herbal products 9) Subjects with abnormal biochemical or haematological values 10) Pregnant or Lactating Women 11) Any condition that in Opinion of the Investigator, does not justify the Subjectsâ?? participation in the study.

Design outcomes

Primary

MeasureTime frame
Change in Energy Expenditure in comparison with baseline valuesTimepoint: Day 0, Day 56

Secondary

MeasureTime frame
Change in Biochemical Markers in comparison with basline valuesTimepoint: Day 0, Day 56;Tolerabily, safety and adverse event assessmentTimepoint: Day 0, Day 28, Day 56

Countries

India

Contacts

Public ContactJestin V Thomas

Akay Flavours and Aromatics Private Limited

Krishnakumar.IM@akay-group.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 6, 2026