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Effect of Nigella Sativa on Lipid Profiles in Elderly

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01531062
Recruitment Status : Completed
First Posted : February 10, 2012
Last Update Posted : February 10, 2012
Information provided by (Responsible Party):
Jimmy Tandradynata, 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.

Condition or disease Intervention/treatment Phase
Dyslipidemia Drug: Nigella sative Dietary Supplement: black sticky rice Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Nigella Sativa on Lipid Profiles in Elderly: a Randomized Double-blinded Clinical Trial
Study Start Date : September 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Arm Intervention/treatment
Experimental: Nigella sativa
Nigella sativa extracts, 300 mg twice daily
Drug: Nigella sative
Nigella sativa seed extracts, 300 mg capsule bid, for 56 days

Placebo Comparator: Placebo Dietary Supplement: black sticky rice
300 mg capsule bid, 56 days

Primary Outcome Measures :
  1. Decreased level of total cholesterol, LDL, dan triglyceride, and increased level of HDL [ Time Frame: 56 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01531062

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Internal Medicine Department, Faculty of Medicine, University Indonesia
Jakarta, Indonesia, 10430
Sponsors and Collaborators
Indonesia University
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Responsible Party: Jimmy Tandradynata, Dr., Indonesia University Identifier: NCT01531062    
Other Study ID Numbers: Nigella sativa
First Posted: February 10, 2012    Key Record Dates
Last Update Posted: February 10, 2012
Last Verified: February 2012
Keywords provided by Jimmy Tandradynata, Indonesia University:
nigella sativa
Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases