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A clinical trial to compare the effect of omega 3 fatty acids between diabetic dyslipidemic patients and non- diabetic dyslipidemic patients

Comparison of the effect of add-on therapy with omega 3 fatty acids between diabetic dyslipidemic patients and non- diabetic dyslipidemic patients â?? A comparative, randomised, open- label , prospective study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/01/022594
Enrollment
50
Registered
2020-01-02
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: E785- Hyperlipidemia, unspecified

Interventions

Intervention1: Omega 3 fatty acids capsules 1 g once daily: Participants of the study will be given 1 gram of omega 3 fatty acid- fish oil capsule per day once daily to take orally for 8 weeks. Contro

Sponsors

Dr E Hephzibah Magdalene
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
PRIMARY ENDPOINT: Lowering of plasma triglycerides from baseline through 8 weeks. Timepoint: Visit 1(0 weeks): Screening, baseline investigations,issue of drug. Visit 2( 3 days) : Enrollment, Randomisation Visit 3( 4 weeks): Vitals, Adverse event monitoring, Investigations Visit 4(8 weeks): Vitals, investigations, Adverse event monitoring.

Secondary

MeasureTime frame
ï?·Lowering of total cholesterol, LDL,VLDL from baseline through 8 weeks.Timepoint: Visit 1(0 weeks): Screening, baseline investigations,issue of drug. Visit 2( 3 days) : Enrollment, Randomisation Visit 3( 4 weeks): Vitals, Adverse event monitoring, Investigations Visit 4(8 weeks): Vitals, investigations, Adverse event monitoring.

Countries

India

Contacts

Public ContactDr E Hephzibah Magdalene

Madras Medical College

msudha1969@gmail.com9840697847

Outcome results

None listed

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