Effect of Nigella Sativa on Lipid Profiles in Elderly

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2011-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Nigella sativa

Nigella sativa extracts, 300 mg twice daily

Group Type EXPERIMENTAL

Nigella sative

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

black sticky rice

Intervention Type DIETARY_SUPPLEMENT

300 mg capsule bid, 56 days

Interventions

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Nigella sative

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

Intervention Type DRUG

black sticky rice

300 mg capsule bid, 56 days

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)