Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06422650
Status:
RECRUITING
Last Update Posted:
2024-05-21
First Post:
2024-05-15
Brief Title:
Effect of Nigella Sativa in Atorvastatin Treated Hyperlipidaemia
Sponsor:
Bangabandhu Sheikh Mujib Medical University Dhaka Bangladesh
Organization:
Bangabandhu Sheikh Mujib Medical University Dhaka Bangladesh
Study Overview
Official Title:
Effect of Nigella Sativa on Blood Lipids as an add-on Therapy in Atorvastatin Treated Hyperlipidaemic Patients A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 SCreatinine 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 hyperlipidemiaThis 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 BMIIn 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
Aim of this study This proposed study is therefore an effort to find out the safety and efficacy of Nigella Sativa in patient with hyperlipidemiaThis 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 BMIIn 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None