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Effect of Nigella Sativa on Lipid Profiles in Elderly

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01531062
First Posted: February 10, 2012
Last Update Posted: February 10, 2012
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.
Information provided by (Responsible Party):
Jimmy Tandradynata, Indonesia University
  Purpose
The purpose of this study is to determine whether Nigella sativa seed extracts are effective in the treatment of dyslipidemia in elderly.

Condition Intervention Phase
Dyslipidemia Drug: Nigella sative Dietary Supplement: black sticky rice Phase 2

Study Type: Interventional
Study Design: 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

Further study details as provided by Jimmy Tandradynata, Indonesia University:

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

Enrollment: 96
Study Start Date: September 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01531062


Locations
Indonesia
Internal Medicine Department, Faculty of Medicine, University Indonesia
Jakarta, Indonesia, 10430
Sponsors and Collaborators
Indonesia University
  More Information

Responsible Party: Jimmy Tandradynata, Dr., Indonesia University
ClinicalTrials.gov Identifier: NCT01531062     History of Changes
Other Study ID Numbers: Nigella sativa
First Submitted: February 8, 2012
First Posted: February 10, 2012
Last Update Posted: February 10, 2012
Last Verified: February 2012

Keywords provided by Jimmy Tandradynata, Indonesia University:
nigella sativa
dyslipidemia
elderly

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases