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RECRUITINGPhase 2INTERVENTIONAL

Effect of Nigella Sativa in Atorvastatin Treated Hyperlipidaemia

Effect of Nigella Sativa on Blood Lipids as an add-on Therapy in Atorvastatin Treated Hyperlipidaemic Patients. A Randomized Controlled Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: 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 Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Nigella Sativa capsule 500mg

Nigella Sativa capsule 500mg twice daily for 8 weeks

DRUG

Placebo

Oral placebo identical to astaxanthin

Locations (1)

BSMMU
Dhaka, Bangladesh