Hyperlipidemia Clinical Trial
Official title:
Effect of Nigella Sativa on Blood Lipids as an add-on Therapy in Atorvastatin Treated Hyperlipidaemic Patients. A Randomized Controlled 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
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00001154 -
Lipoprotein Metabolism in Normal Volunteers and Patients With High Levels of Lipoproteins
|
||
| Completed |
NCT02927184 -
Safety and Tolerability of VK2809 in Patients With Primary Hypercholesterolemia and Non-Alcoholic Fatty Liver Disease
|
Phase 2 | |
| Completed |
NCT04640012 -
Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics of DC371739 Single-Dose Treatment in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT03213288 -
Bilberry Fruit and Black Rice Derived Anthocyanins on Lipid Status
|
N/A | |
| Completed |
NCT00382564 -
Magnetic Resonance Angiography to Diagnose Atherosclerotic Disease
|
N/A | |
| Recruiting |
NCT02979704 -
A Comparative Study of Rosuvastatin and Atorvastatin in Patients With Hyperlipidemia
|
Phase 2/Phase 3 | |
| Completed |
NCT02569814 -
A Study to Compare the Pharmacokinetics and Safety of a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin
|
Phase 1 | |
| Completed |
NCT02428998 -
Safety for 24 Weeks Intake of Korean Red Ginseng in Adults
|
N/A | |
| Completed |
NCT02280590 -
Comparison of the Efficacy and Safety of Cresnon® and Crestor® in Patients With Hyperlipidemia
|
Phase 4 | |
| Completed |
NCT01678183 -
Financial Incentives for Medication Adherence
|
N/A | |
| Completed |
NCT01426412 -
A Study of LY3015014 in Healthy Participants With Elevated Low Density Lipoprotein Cholesterol
|
Phase 1 | |
| Completed |
NCT01694446 -
Regulation of Intestinal and Hepatic Lipoprotein Production by Glucose and Fructose
|
N/A | |
| Completed |
NCT01131832 -
Genetic Basis for Heterogeneity in Response of Plasma Lipids to Plant Sterols
|
Phase 4 | |
| Completed |
NCT00758303 -
A Study to Evaluate the Lipid Regulating Effects of TRIA-662
|
Phase 2/Phase 3 | |
| Completed |
NCT00534105 -
Lipid Metabolism in Gestational Diabetes
|
N/A | |
| Recruiting |
NCT00408824 -
Investigation of Genetic Risk of Metabolic Syndrome in Company Employee (NGK Study)
|
N/A | |
| Completed |
NCT00362206 -
Comparison of the Combination of Fenofibrate and Simvastatin Versus Pravastatin
|
Phase 3 | |
| Terminated |
NCT00299169 -
Randomized Trial Comparing N of 1 Trials to Standard Practice to Improve Adherence to Statins in Patients With Diabetes
|
Phase 4 | |
| Completed |
NCT00381992 -
Risk Assessment of Long-Haul Truck Drivers
|
N/A | |
| Completed |
NCT00414986 -
Using Learning Teams for Reflective Adaptation for Diabetes and Depression
|
N/A |