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Effectiveness of Nigella Sativa (Kalonji) Seed in Dyslipidemia

This study has been completed.
Sponsor:
Information provided by:
Aga Khan University
ClinicalTrials.gov Identifier:
NCT00327054
First received: May 16, 2006
Last updated: June 13, 2007
Last verified: April 2007
History of Changes
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effectiveness of Nigella Sativa (Kalonji) Seed in Dyslipidemia: A Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

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
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:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

Keywords provided by Aga Khan University:
Dyslipidaemia
Herbal medicine
Home remedy
Alternative medicine
Metabolic syndrome

Additional relevant MeSH terms:
Diabetes Mellitus
Hypercholesterolemia
Hypertension
Dyslipidemias
Metabolic Syndrome X
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Hyperlipidemias
Lipid Metabolism Disorders
Vascular Diseases
Cardiovascular Diseases
Insulin Resistance
Hyperinsulinism

ClinicalTrials.gov processed this record on May 23, 2013