MedPath

Effect of Nigella Sativa on Lipid Profiles in Elderly

Phase 2
Completed
Conditions
Dyslipidemia
Interventions
Drug: Nigella sative
Dietary Supplement: black sticky rice
Registration Number
NCT01531062
Lead Sponsor
Indonesia University
Brief Summary

The purpose of this study is to determine whether Nigella sativa seed extracts are effective in the treatment of dyslipidemia in elderly.

Detailed Description

Cardiovascular diseases are still common health problems worldwide. They are major causes of morbidity and mortality in many countries. Dyslipidemia is the main risk factor of cardiovascular events. Despite the invention of many conventional hypolipidemic drugs, the use of traditional medicine remains high, especially in elderly patients. However, evidence of the effectiveness of many herbs or other traditional drugs is lacking. Nigella sativa or black seeds are traditional herbs used for years in Middle East and India. They are believed to cure many diseases, including dyslipidemia. Therefore, a study is needed to prove their effectiveness as their use might improve our strategy to improve patients' compliance.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
96
Inclusion Criteria
  • age of 60 years or more
  • having dyslipidemia (total cholesterol >200 mg/dL or LDL >100 mg/dL or triglyceride > 150 mg/dL or HDL < 40 mg/dL (male) or HDL < 50 mg/dL (female)
Exclusion Criteria
  • ALT or AST are two times of upper normal limit
  • creatinine clearance test is below 30

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Nigella sativaNigella sativeNigella sativa extracts, 300 mg twice daily
Placeboblack sticky rice-
Primary Outcome Measures
NameTimeMethod
Decreased level of total cholesterol, LDL, dan triglyceride, and increased level of HDL56 days
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Internal Medicine Department, Faculty of Medicine, University Indonesia

🇮🇩

Jakarta, Indonesia

© Copyright 2025. All Rights Reserved by MedPath