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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Dyslipidemias
Hypercholesterolemia
Hypertension
Metabolic Syndrome X
Syndrome
Cardiovascular Diseases
Disease
Endocrine System Diseases
Glucose Metabolism Disorders
Hyperinsulinism
Hyperlipidemias
Insulin Resistance
Lipid Metabolism Disorders
Metabolic Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014