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Completed

NCT Number: NCT01531062

Effect of Nigella Sativa on Lipid Profiles in Elderly

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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Key information

Conditions

Dyslipidemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Internal Medicine Department, Faculty of Medicine, University Indonesia

Jakarta, Jakarta Special Capital Region, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nigella sative

Drug

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

black sticky rice

Dietary Supplement

300 mg capsule bid, 56 days

Primary outcomes

  1. Decreased level of total cholesterol, LDL, dan triglyceride, and increased level of HDL

    Time frame: 56 days

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Feb 10, 2012
Registry last updated
Feb 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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