Effectiveness of Nigella Sativa (Kalonji) Seed in Dyslipidemia
|First Received Date ICMJE||May 16, 2006|
|Last Updated Date||June 13, 2007|
|Start Date ICMJE||February 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||The primary end point for the trial is serum low-density lipoprotein (LDL) cholesterol concentration measured at six weeks after intervention.|
|Original Primary Outcome Measures ICMJE
||The primary end point for the trial is serum LDL cholesterol concentration measured at six weeks after intervention.|
|Change History||Complete list of historical versions of study NCT00327054 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Effectiveness of Nigella Sativa (Kalonji) Seed in Dyslipidemia|
|Official Title ICMJE||Effectiveness of Nigella Sativa (Kalonji) Seed in Dyslipidemia: A Randomized Controlled Trial|
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.
To determine the effectiveness of the nigella sativa seed in the control of dyslipidemia in adults. This is a pilot study.
Double blind, randomized, controlled trial
The primary end point for the trial is serum LDL cholesterol concentration measured at six weeks after intervention.
Intervention Group Recommended
Control Group Recommended
Study subjects will receive advice from the Principal Investigator (PI)
Subjects in both groups will be advised to take a brisk 30 minute walk for 5 days in a week on empty stomach or one hour after having a meal.
For lab investigations venous blood specimens will be collected for the following tests. The tests will be performed on 12 hour fasting samples to assess the primary and secondary outcomes.
IDENTIFICATION OF STUDY SUBJECTS
Study subjects will be identified from executive and family medicine clinics within AKUH. Individuals fulfilling the inclusion criteria will be informed about the study and asked to participate.
FOLLOW–UP & DATA COLLECTION
SAMPLE SIZE CONSIDERATIONS
This is a pilot study and will include 80 patients. Half will get N. Sativa seed capsules and the rest will get calcium lactate placebo capsules.
Aga Khan University Hospital (AKUH), Karachi
|Study Type ICMJE||Interventional|
|Study Phase||Phase 1
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Intervention ICMJE||Drug: Nigella sativa seed|
|Study Arm (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||March 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 70 Years|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Pakistan|
|NCT Number ICMJE||NCT00327054|
|Other Study ID Numbers ICMJE||05201MED(Grant Fund#1VJ)|
|Has Data Monitoring Committee||No|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Aga Khan University|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Aga Khan University|
|Verification Date||April 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP