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Effect of Nigella Sativa on Lipid Profiles in Elderly

U

University of Indonesia (UI)

Status and phase

Completed
Phase 2

Conditions

Dyslipidemia

Treatments

Drug: Nigella sative
Dietary Supplement: black sticky rice

Study type

Interventional

Funder types

Other

Identifiers

NCT01531062
Nigella sativa

Details and patient eligibility

About

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

Full 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.

Enrollment

96 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

96 participants in 2 patient groups, including a placebo group

Nigella sativa
Experimental group
Description:
Nigella sativa extracts, 300 mg twice daily
Treatment:
Drug: Nigella sative
Placebo
Placebo Comparator group
Treatment:
Dietary Supplement: black sticky rice

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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