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CompletedNCT01531062Updated Feb 10, 2012

Effect of Nigella Sativa on Lipid Profiles in Elderly

A Phase 2 interventional study of Nigella sative and black sticky rice in Dyslipidemia, sponsored by Indonesia University. Completed at 1 site in Indonesia. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2012-02-10.

Sponsored by Indonesia University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Dyslipidemia

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Keywords

  • nigella sativa
  • dyslipidemia
  • elderly
03

In context

Dyslipidemias

1,073 studies on the registry are indexed under Dyslipidemias; 158 are open to participants now.

This study's enrollment of 96 is close to the median of 99 across 842 interventional studies indexed under Dyslipidemias.

Browse Dyslipidemias studies →

Lead sponsor

Indonesia University is the lead sponsor of 448 studies on the registry; 56 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
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

Exclusion Criteria:

  • ALT or AST are two times of upper normal limit
  • creatinine clearance test is below 30
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
96 participants (actual)

Study arms

  • Experimental
    Nigella sativa

    Nigella sativa extracts, 300 mg twice daily

    Drug: Nigella sative

  • Placebo comparator
    Placebo

    Dietary Supplement: black sticky rice

Interventions

  • DrugNigella sative

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

  • Dietary supplementblack sticky rice

    300 mg capsule bid, 56 days

06

What researchers measure

Primary outcomes

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

    Time frame: 56 days

07

Study locations

1 site
  • Internal Medicine Department, Faculty of Medicine, University Indonesia
    Jakarta, 10430, Indonesia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01531062
Lead sponsor
Indonesia University
Responsible party
Jimmy Tandradynata (Dr., Indonesia University) — Principal investigator
First posted
Feb 10, 2012
Start date
Sep 2011
Primary completion
Dec 2011
Completion
Dec 2011
Last update
Feb 10, 2012

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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