NCT00327054

Brief Summary

This is a pilot study. The aim of the investigators' study is to evaluate the effectiveness of nigella sativa seed in the treatment of dyslipidemia. Dyslipidemia is a common risk factor for cardiovascular disease, the leading cause for morbidity and mortality among patients. Nigella sativa is an easily available and acceptable remedy to treat dyslipidemia and at a low cost. It is expected that by scientifically determining the effectiveness of this intervention it will lead to its widespread use. This will provide a low cost alternative to treat dyslipidemia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2006

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

February 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 17, 2006

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

July 1, 2015

Status Verified

April 1, 2007

First QC Date

May 16, 2006

Last Update Submit

June 30, 2015

Conditions

HypercholesterolemiaHypertensionDiabetes MellitusMetabolic Syndrome X

Keywords

DyslipidaemiaHerbal medicineHome remedyAlternative medicineMetabolic syndrome

Outcome Measures

Primary Outcomes (1)

  • The primary end point for the trial is serum low-density lipoprotein (LDL) cholesterol concentration measured at six weeks after intervention.

    six weeks

Secondary Outcomes (6)

  • Serum total cholesterol concentrations measured at six weeks after intervention

    six weeks

  • Serum concentrations of high-density lipoprotein (HDL) cholesterol measured at six weeks after intervention

    six weeks

  • Serum triglyceride concentrations measured at six weeks after intervention

    six weeks

  • Serum blood sugar concentrations measured at six weeks after intervention

    six weeks

  • Blood pressure measured at six weeks after intervention

    six weeks

  • +1 more secondary outcomes

Study Arms (2)

Nigella sativa seed

EXPERIMENTAL
Drug: Nigella sativa seed

Control

NO INTERVENTION

Interventions

Nigella sativa seedDRUG
Nigella sativa seed

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult (18 years or older) men and women
  • Serum cholesterol \> 180 mgs/dl
  • Provide Informed Consent

You may not qualify if:

  • Diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aga Khan University

Karachi, Sindh, 74800, Pakistan

Location

Related Publications (5)

  • Ismail J, Jafar TH, Jafary FH, White F, Faruqui AM, Chaturvedi N. Risk factors for non-fatal myocardial infarction in young South Asian adults. Heart. 2004 Mar;90(3):259-63. doi: 10.1136/hrt.2003.013631.

    PMID: 14966040BACKGROUND

  • Ali BH, Blunden G. Pharmacological and toxicological properties of Nigella sativa. Phytother Res. 2003 Apr;17(4):299-305. doi: 10.1002/ptr.1309.

    PMID: 12722128BACKGROUND

  • Zaoui A, Cherrah Y, Alaoui K, Mahassine N, Amarouch H, Hassar M. Effects of Nigella sativa fixed oil on blood homeostasis in rat. J Ethnopharmacol. 2002 Jan;79(1):23-6. doi: 10.1016/s0378-8741(01)00342-7.

    PMID: 11744291BACKGROUND

  • El-Saleh SC, Al-Sagair OA, Al-Khalaf MI. Thymoquinone and Nigella sativa oil protection against methionine-induced hyperhomocysteinemia in rats. Int J Cardiol. 2004 Jan;93(1):19-23. doi: 10.1016/s0167-5273(03)00108-6.

    PMID: 14729430BACKGROUND

  • Qidwai W, Hamza HB, Qureshi R, Gilani A. Effectiveness, safety, and tolerability of powdered Nigella sativa (kalonji) seed in capsules on serum lipid levels, blood sugar, blood pressure, and body weight in adults: results of a randomized, double-blind controlled trial. J Altern Complement Med. 2009 Jun;15(6):639-44. doi: 10.1089/acm.2008.0367.

    PMID: 19500003DERIVED

MeSH Terms

Conditions

HypercholesterolemiaHypertensionDiabetes MellitusMetabolic SyndromeDyslipidemias

Interventions

Nigella sativa oil

Condition Hierarchy (Ancestors)

HyperlipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesVascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersEndocrine System DiseasesInsulin ResistanceHyperinsulinism

Study Officials

  • Waris - Qidwai

    Aga Khan University, Karachi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 16, 2006

First Posted

May 17, 2006

Study Start

February 1, 2006

Study Completion

March 1, 2007

Last Updated

July 1, 2015

Record last verified: 2007-04

Locations

PA(1)