Effect of Nigella Sativa on Lipid Profiles in Elderly

Dyslipidemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01531062
• Other study ID #: Nigella sativa
• Status: Completed
• Phase: Phase 2
• First received: February 8, 2012
• Last updated: February 8, 2012
• Start date: September 2011
• Est. completion date: December 2011

Study information

• Verified date: February 2012
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indonesia: Departement Kesehatan (Department of Health)
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Drug:
• Nigella sative
Nigella sativa seed extracts, 300 mg capsule bid, for 56 days

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

Locations

Country	Name	City	State
Indonesia	Internal Medicine Department, Faculty of Medicine, University Indonesia	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decreased level of total cholesterol, LDL, dan triglyceride, and increased level of HDL		56 days	Yes