Effectiveness of Nigella Sativa (Kalonji) Seed in Dyslipidemia - Full Text View

Sponsored by:	Aga Khan University
Information provided by:	Aga Khan University
ClinicalTrials.gov Identifier:	NCT00327054

Purpose

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.

Condition	Intervention	Phase
Hypercholesterolemia Hypertension Diabetes Mellitus Metabolic Syndrome X	Drug: Nigella sativa seed	Phase I Phase II

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Diabetes High Blood Pressure Metabolic Syndrome

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Effectiveness of Nigella Sativa (Kalonji) Seed in Dyslipidemia: A Randomized Controlled Trial

Further study details as provided by Aga Khan University:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Serum total cholesterol concentrations measured at six weeks after intervention
Serum concentrations of high-density lipoprotein (HDL) cholesterol measured at six weeks after intervention
Serum triglyceride concentrations measured at six weeks after intervention
Serum blood sugar concentrations measured at six weeks after intervention
Blood pressure measured at six weeks after intervention
Changes in ALT (SGPT) and serum creatinine after six weeks intervention

Estimated Enrollment:	80
Study Start Date:	February 2006
Study Completion Date:	March 2007

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Diabetes mellitus

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00327054

Locations

Pakistan, Sindh
Aga Khan University
Karachi, Sindh, Pakistan, 74800

Sponsors and Collaborators

Aga Khan University

Investigators

Principal Investigator:

Waris - Qidwai

Aga Khan University, Karachi

More Information

Publications:

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.

Ali BH, Blunden G. Pharmacological and toxicological properties of Nigella sativa. Phytother Res. 2003 Apr;17(4):299-305. Review.

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.

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.

Study ID Numbers:	05201MED(Grant Fund#1VJ)
Study First Received:	May 16, 2006
Last Updated:	June 13, 2007
ClinicalTrials.gov Identifier:	NCT00327054
Health Authority:	Pakistan: Research Ethics Committee

Keywords provided by Aga Khan University:

Dyslipidaemia
Herbal medicine
Home remedy
Alternative medicine
Metabolic syndrome

Study placed in the following topic categories:

Metabolic Syndrome X
Metabolic Diseases
Hyperlipidemias
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases
Hyperinsulinism
Syndrome X
Endocrinopathy

Insulin Resistance
Metabolic disorder
Glucose Metabolism Disorders
Hypercholesterolemia
Abdominal obesity metabolic syndrome
Dyslipidemias
Hypertension
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009