Effect of Nigella Sativa in Atorvastatin Treated Hyperlipidaemia

NCT ID: NCT06422650

Last Updated: 2024-05-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-24
• Study Completion Date: 2024-08-31

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Nigella Sativa

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

Group Type: EXPERIMENTAL

Nigella Sativa capsule 500mg

Intervention Type: DRUG

Nigella Sativa capsule 500mg twice daily for 8 weeks

Control

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral placebo identical to astaxanthin

Interventions

Nigella Sativa capsule 500mg

Nigella Sativa capsule 500mg twice daily for 8 weeks

Intervention Type: DRUG

Placebo

Oral placebo identical to astaxanthin

Intervention Type: DRUG

Other Intervention Names

Black seed oil

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

OTHER

Sponsor Role: lead

Responsible Party

Farzana Siddiqua

Resident, MD, Pharmacology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Farzana Siddiqua, MBBS

Role: PRINCIPAL_INVESTIGATOR

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Locations

BSMMU

Dhaka, , Bangladesh

Site Status: RECRUITING

Countries

Bangladesh

Central Contacts

Farzana Siddiqua, MBBS

Role: CONTACT

farzanamony12@gmail.com

01842378736

Adhir K Das

Role: CONTACT

01711961097

Facility Contacts

Farzana Siddiqua, MBBS

Role: primary

farzanamony12@gmail.com

01842378736

Other Identifiers

BSMMU/2023/11004

Identifier Type: -

Identifier Source: org_study_id