Effect of Nigella Sativa in Atorvastatin Treated Hyperlipidaemia

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Status and phase: Enrolling; Phase 2

Conditions: Hyperlipidemia

Treatments: Drug: Nigella Sativa capsule 500mg; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06422650

BSMMU/2023/11004

Details and patient eligibility

About

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

Full description

Hyperlipidemia is one of the most important risk factors to cause atherosclerosis that ultimately triggers cardiovascular complications like myocardial infarction, ischemic stroke, peripheral vascular disease etc. These are considered as the leading cause of mortality and morbidity worldwide. Nigella sativa has both lipid lowering and anti-oxidant potentials. In this regard Nigella Sativa can be given with standard therapy to regulate blood lipids.

Aim of this study: This proposed study is therefore an effort to find out the safety and efficacy of Nigella Sativa in patient with hyperlipidemia.This study will be a single center study, utilizing a randomized, double-blind, placebo controlled trial. It will be conducted in the department of pharmacology, BSMMU in collaboration with the department of cardiology, BSMMU from the day of approval by the Institutional Review Board to June, 2024. The study will involve a total of Eighty four (84) patients attended in the outpatient department of cardiology, BSMMU, diagnosed as hyperlipidemia, with 42 of them receiving standard treatment along with a twice daily dose of 500mg of Nigella Sativa capsule for 8 weeks. The remaining 42 patients will undergo standard treatment along with a placebo over the same duration. The data collected will be analyzed through descriptive statistical techniques, offering a comprehensive summary of the results. In this study we will assess various sociodemographic characteristics of all the participants, including like age, sex, body mass index (BMI).In addition to these factors we will also evaluate their lipid profile, serum glutamic pyruvic transaminase (SGPT), serum creatinine level at baseline and after 8 weeks of interventions. Addition of Nigella Sativa with the conventional treatment of Statin could potentially reduce blood lipids in patients with hyperlipidemia.

Enrollment: 84 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 2 patient groups, including a placebo group

Nigella Sativa

Experimental group

Description:

Patients will receive Nigella Sativa (500mg) capsule twice daily for 8 weeks.

Treatment:

Drug: Nigella Sativa capsule 500mg

Control

Placebo Comparator group

Description:

Patients will receive capsules of placebo twice daily for 8 weeks.

Treatment:

Drug: Placebo