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Effectiveness of Nigella Sativa (Kalonji) Seed in Dyslipidemia

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ClinicalTrials.gov Identifier: NCT00327054
Recruitment Status : Completed
First Posted : May 17, 2006
Last Update Posted : July 1, 2015
Sponsor:
Information provided by:
Aga Khan University

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.


Condition or disease Intervention/treatment Phase
Hypercholesterolemia Hypertension Diabetes Mellitus Metabolic Syndrome X Drug: Nigella sativa seed Phase 1 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effectiveness of Nigella Sativa (Kalonji) Seed in Dyslipidemia: A Randomized Controlled Trial
Study Start Date : February 2006
Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Nigella sativa seed Drug: Nigella sativa seed
No Intervention: Control



Primary Outcome Measures :
  1. The primary end point for the trial is serum low-density lipoprotein (LDL) cholesterol concentration measured at six weeks after intervention. [ Time Frame: six weeks ]

Secondary Outcome Measures :
  1. Serum total cholesterol concentrations measured at six weeks after intervention [ Time Frame: six weeks ]
  2. Serum concentrations of high-density lipoprotein (HDL) cholesterol measured at six weeks after intervention [ Time Frame: six weeks ]
  3. Serum triglyceride concentrations measured at six weeks after intervention [ Time Frame: six weeks ]
  4. Serum blood sugar concentrations measured at six weeks after intervention [ Time Frame: six weeks ]
  5. Blood pressure measured at six weeks after intervention [ Time Frame: six weeks ]
  6. Changes in serum creatinine after six weeks intervention [ Time Frame: six weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
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)
First Posted: May 17, 2006    Key Record Dates
Last Update Posted: July 1, 2015
Last Verified: April 2007

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

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