Effect of Nigella Sativa on Lipid Profiles in Elderly

Effect of Nigella Sativa on Lipid Profiles in Elderly: a Randomized Double-blinded Clinical Trial

Sponsors

Lead Sponsor: Indonesia University

Source 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.

Overall Status Completed
Start Date 2011-09-01
Completion Date 2011-12-01
Primary Completion Date 2011-12-01
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Decreased level of total cholesterol, LDL, dan triglyceride, and increased level of HDL 56 days
Enrollment 96
Condition
Intervention

Intervention Type: Drug

Intervention Name: Nigella sative

Description: Nigella sativa seed extracts, 300 mg capsule bid, for 56 days

Arm Group Label: Nigella sativa

Intervention Type: Dietary Supplement

Intervention Name: black sticky rice

Description: 300 mg capsule bid, 56 days

Arm Group Label: Placebo

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

60 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Location
Facility: Internal Medicine Department, Faculty of Medicine, University Indonesia
Location Countries

Indonesia

Verification Date

2012-02-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Indonesia University

Investigator Full Name: Jimmy Tandradynata

Investigator Title: Dr.

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Nigella sativa

Type: Experimental

Description: Nigella sativa extracts, 300 mg twice daily

Label: Placebo

Type: Placebo Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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