NCT06422650 Effect of Nigella Sativa in Atorvastatin Treated Hyperlipidaemia
| NCT ID | NCT06422650 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh |
| Condition | Hyperlipidemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2023-08-24 |
| Primary Completion | 2024-08-31 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This study will be 8 weeks randomized, double-blind, placebo-controlled trail to assess the effect of Nigella Sativa in 84 Hyperlipidaemic patients. Participants will be assessed at baseline and after 8 weeks of intervention. Subjects will be randomized to receive either Nigella Sativa 500 mg capsule daily or placebo capsule identical to Nigella Sativa twice daily for 8 weeks. Evaluation of lipid profile, SGPT, S.Creatinine will be before and after 8 weeks of intervention. Nigella Sativa related adverse events will be identified. Study outcome will establish safety and efficacy of Nigella Sativa in atorvastatin treated hyperlipidaemic patients
Eligibility 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