NCT01531062

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 10, 2012

Completed
Last Updated

February 10, 2012

Status Verified

February 1, 2012

Enrollment Period

3 months

First QC Date

February 8, 2012

Last Update Submit

February 8, 2012

Conditions

Dyslipidemia

Keywords

nigella sativadyslipidemiaelderly

Outcome Measures

Primary Outcomes (1)

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

    56 days

Study Arms (2)

Nigella sativa

EXPERIMENTAL

Nigella sativa extracts, 300 mg twice daily

Drug: Nigella sative

Placebo

PLACEBO COMPARATOR
Dietary Supplement: black sticky rice

Interventions

Nigella sativeDRUG

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

Nigella sativa
black sticky riceDIETARY_SUPPLEMENT

300 mg capsule bid, 56 days

Placebo

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Internal Medicine Department, Faculty of Medicine, University Indonesia

Jakarta, Jakarta Special Capital Region, 10430, Indonesia

Location

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

February 8, 2012

First Posted

February 10, 2012

Study Start

September 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

February 10, 2012

Record last verified: 2012-02

Locations

ID(1)