Effect of Nigella Sativa on Lipid Profiles in Elderly

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

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

Study Overview

• Status: Completed
• Conditions: Dyslipidemia
• Intervention / Treatment: Drug: Nigella sative; Dietary supplement: black sticky rice

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.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 2

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta, Indonesia, 10430
    • Internal Medicine Department, Faculty of Medicine, University Indonesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Dietary supplement: black sticky rice; 300 mg capsule bid, 56 days
EXPERIMENTAL: Nigella sativa; Nigella sativa extracts, 300 mg twice daily	Drug: Nigella sative; Nigella sativa seed extracts, 300 mg capsule bid, for 56 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Decreased level of total cholesterol, LDL, dan triglyceride, and increased level of HDL	56 days

Collaborators and Investigators

• Sponsor: Indonesia University

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (ACTUAL): December 1, 2011
• Study Completion (ACTUAL): December 1, 2011

Study Registration Dates

• First Submitted: February 8, 2012
• First Submitted That Met QC Criteria: February 8, 2012
• First Posted (ESTIMATE): February 10, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): February 10, 2012
• Last Update Submitted That Met QC Criteria: February 8, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: elderly; dyslipidemia; nigella sativa
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID Numbers: Nigella sativa