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Effect of Nigella Sativa on Lipid Profiles in Elderly

Primary Purpose

Dyslipidemia

Status

Completed

Phase

Phase 2

Locations

Indonesia

Study Type

Interventional

Intervention

Nigella sative

black sticky rice

About this trial

This is an interventional treatment trial for Dyslipidemia focused on measuring nigella sativa, dyslipidemia, elderly

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Internal Medicine Department, Faculty of Medicine, University Indonesia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nigella sativa

Placebo

Arm Description

Nigella sativa extracts, 300 mg twice daily

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01531062

First Posted

February 8, 2012

Last Updated

February 8, 2012

Sponsor

Indonesia University

1. Study Identification

Unique Protocol Identification Number

NCT01531062

Brief Title

Effect of Nigella Sativa on Lipid Profiles in Elderly

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Completed

Study Start Date

September 2011 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indonesia University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dyslipidemia

Keywords

nigella sativa, dyslipidemia, elderly

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

96 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nigella sativa

Arm Type

Experimental

Arm Description

Nigella sativa extracts, 300 mg twice daily

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Nigella sative

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

black sticky rice

Intervention Description

300 mg capsule bid, 56 days

Primary Outcome Measure Information:

Title

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

Time Frame

56 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Internal Medicine Department, Faculty of Medicine, University Indonesia

City

Jakarta

ZIP/Postal Code

10430

Country

Indonesia

12. IPD Sharing Statement

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Effect of Nigella Sativa on Lipid Profiles in Elderly

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