Evaluating Nigella Sativa's effect on cholesterol levels in patients taking atorvastatin
Effect of Nigella Sativa on Blood Lipids as an add-on Therapy in Atorvastatin Treated Hyperlipidaemic Patients. A Randomized Controlled Trial
This study is testing if taking Nigella Sativa along with atorvastatin can help lower cholesterol levels in people with high cholesterol.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh Academic / other |
| Locations | 1 site (Dhaka) |
| Trial ID | NCT06422650 on ClinicalTrials.gov |
What this trial studies
This clinical trial is an 8-week randomized, double-blind, placebo-controlled study designed to assess the safety and efficacy of Nigella Sativa in patients with hyperlipidemia who are already being treated with atorvastatin. A total of 84 participants will be enrolled, with half receiving a daily dose of 500 mg of Nigella Sativa and the other half receiving a placebo. The study will evaluate changes in lipid profiles, liver function, and kidney function before and after the intervention. Adverse events related to Nigella Sativa will also be monitored throughout the study period.
Who should consider this trial
Good fit: Ideal candidates for this study are newly diagnosed hyperlipidemic patients, both male and female, who are also suffering from ischemic heart disease, diabetes mellitus, or hypertension.
Not a fit: Patients with renal impairment, active liver disease, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a complementary treatment option for patients with hyperlipidemia, potentially improving their lipid profiles and reducing cardiovascular risks.
How similar studies have performed: While the use of Nigella Sativa for lipid management is promising, this specific approach has not been extensively tested in similar studies, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Newly diagnosed hyperlipidaemic patient. 2. Both male and female 3. Hyperlipidemic patients suffering from ischemic heart disease, diabetes mellitus, hypertension 4. Diagnostic criteria for dyslipidemic patients 1. Total cholesterol 200mg/dl 2. LDL-C 140mg/dl 3. Triglyceride 150mg/dl 4. HDL \<40mg/dl Exclusion Criteria: 1. Patients with renal impairment 2. Patients with active liver disease 3. Patients having history of hypersensitivity on any member of statins 4. Pregnant woman. 5. lactating mother
Where this trial is running
Dhaka
- Bsmmu — Dhaka, Bangladesh (Recruiting)
Study contacts
- Principal investigator: Farzana Siddiqua, MBBS — Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Study coordinator: Farzana Siddiqua, MBBS
- Email: farzanamony12@gmail.com
- Phone: 01842378736
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.