Study for safety and efficacy of Eicosapentaenoic acid in adult human male and female subjects with abdominal obesity.
- Conditions
- Health Condition 1: null- Hyperlipidemic
- Registration Number
- CTRI/2013/12/004220
- Lead Sponsor
- Parry Neutraceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method