A clinical trial to compare the effect of omega 3 fatty acids between diabetic dyslipidemic patients and non- diabetic dyslipidemic patients
Not Applicable
Completed
- Conditions
- Health Condition 1: E785- Hyperlipidemia, unspecified
- Registration Number
- CTRI/2020/01/022594
- Lead Sponsor
- Dr E Hephzibah Magdalene
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 53
Inclusion Criteria
ï?·Patients of Type 2 Diabetic Dyslipidemia on anti-diabetic and hypolipidemic drugs for more than 3 months.
ï?·Patients of non- diabetic dyslipidemia.
Exclusion Criteria
1.Patients with sea-food allergy
2.Patients with bleeding disorders, liver diseases.
3.Patients on anti-coagulants, oral contraceptive pills and immunosuppressants.
4.Patients who are not willing to give consent to participate in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PRIMARY ENDPOINT: <br/ ><br>Lowering of plasma triglycerides from baseline through 8 weeks. <br/ ><br>Timepoint: Visit 1(0 weeks): Screening, baseline investigations,issue of drug. <br/ ><br>Visit 2( 3 days) : Enrollment, Randomisation <br/ ><br>Visit 3( 4 weeks): Vitals, Adverse event monitoring, Investigations <br/ ><br>Visit 4(8 weeks): Vitals, investigations, Adverse event monitoring. <br/ ><br>
- Secondary Outcome Measures
Name Time Method ï?·Lowering of total cholesterol, LDL,VLDL from baseline through 8 weeks.Timepoint: Visit 1(0 weeks): Screening, baseline investigations,issue of drug. <br/ ><br>Visit 2( 3 days) : Enrollment, Randomisation <br/ ><br>Visit 3( 4 weeks): Vitals, Adverse event monitoring, Investigations <br/ ><br>Visit 4(8 weeks): Vitals, investigations, Adverse event monitoring.