Dyslipidemia
Conditions
Keywords
nigella sativa, dyslipidemia, elderly
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.
Interventions
DRUGNigella sative
Nigella sativa seed extracts, 300 mg capsule bid, for 56 days
DIETARY_SUPPLEMENTblack sticky rice
300 mg capsule bid, 56 days
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decreased level of total cholesterol, LDL, dan triglyceride, and increased level of HDL | 56 days |
Countries
Indonesia
Outcome results
None listed