NCT06422650

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• Hyperlipidemia

Interventions

Type	Name	Description
DRUG	Nigella Sativa capsule 500mg	Nigella Sativa capsule 500mg twice daily for 8 weeks
DRUG	Placebo	Oral placebo identical to astaxanthin

Timeline

• Start date: 2023-08-24
• Primary completion: 2024-08-31
• Completion: 2024-08-31
• First posted: 2024-05-21
• Last updated: 2024-05-21

Locations

1 site across 1 country: Bangladesh