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Study for safety and efficacy of Eicosapentaenoic acid in adult human male and female subjects with abdominal obesity.

A single blind randomized, single centre,prospective, three treatment, placebo controlled, clinical study to evaluate the safety and efficacy of EPA in adult human male and female subjects with abdominal obesity.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/12/004220
Enrollment
18
Registered
2013-12-16
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: null- Hyperlipidemic

Interventions

Intervention1: EPA A: Eicosapentaenoic acid: 500 mg daily three doses for 3 months Intervention2: EPA B: EPA + Flucoxanthin Eicosapentaenoic acid and Flucoxanthin: 500 mg daily three doses for three m

Sponsors

Parry Neutraceuticals
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult male and female subjects between 18 and 50 yrs (both years inclusive) Willingness to provide written informed consent to participate in the study Understanding the nature and purpose of the study and willing to comply with study procedures Abdominal girth of more than or equal to 102 cm Serum triglycerides equal to or greater than 150 mg/dL and HDL cholesterol Less than 40 mg/dL Negative for HIV 1 & 2, Hepatitis B & C

Exclusion criteria

Exclusion criteria: Subjects not capable of understanding the informed consent Subjects who are on lipid lowering treatment including Statins, fibrates, etc or who are in need of lipid lowering treatment. Subjects with significant hyperglycemia and / or systemic hypertension with related complications including, renal, hepatic, retinal, cardiac, cerebral disorders. Obesity because of identified etiologies such as Cushingâ??s syndrome, hypothyroidism, etc. On a treatment regimen that includes metformin or glitazones

Design outcomes

Primary

MeasureTime frame
The primary objective of the study is to evaluate Safety of EPA in adult human male and female subjects with abdominal obesity.Timepoint: 3 months

Secondary

MeasureTime frame
The secondary objective of the study is to determine the Effiacay of EPA in adult human male and female subjects with abdominal obesity.Timepoint: 3 month

Countries

India

Contacts

Public ContactDr Devesh Kumar

Project Manager

devesh.kumar@fortis-cro.com9971169602

Outcome results

None listed

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