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Benefits of Nigella Sativa in Children With Beta Thalassemia Major (Nigella)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02816957
Recruitment Status : Unknown
Verified June 2016 by Tanta University.
Recruitment status was:  Recruiting
First Posted : June 29, 2016
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Tanta University

Tracking Information
First Submitted Date  ICMJE June 23, 2016
First Posted Date  ICMJE June 29, 2016
Last Update Posted Date April 26, 2017
Study Start Date  ICMJE June 2016
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2016)
  • malondialdehyde [ Time Frame: 3 months ]
    nmol serum level of malondialdehyde (nmol per liter)
  • cluster of differentation4 and 8(CD4 and CD8) [ Time Frame: 3 months ]
    CD4 and CD8 cell per cmm
  • total antioxidant [ Time Frame: 3 months ]
    total antioxidant(mmol per liter)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2016)
  • Serum iron [ Time Frame: 3 months ]
    microgram per dl
  • total iron binding capacity [ Time Frame: 3 months ]
    microgram per dl
  • serum ferritin [ Time Frame: 3 months ]
    ng per ml
  • complete blood count [ Time Frame: 3 months ]
    complete blood count
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Benefits of Nigella Sativa in Children With Beta Thalassemia Major
Official Title  ICMJE Study of The Therapeutic Benefits of Nigella Sativa in Children With Beta Thalassemia Major
Brief Summary Evaluate the therapeutic effects health benefits, and immunological effect of Nigella sativa in children with beta thalassemia major.
Detailed Description

Study will be carried on children patients with β- thalassemia major attending The Hematology Unit of Pediatric Department at Tanta University Hospital. patients are divided into 2 groups: patients in the control group, patients in the treatment group that will receive nigella sativa powder for 3 consecutive months. Then Evaluate the therapeutic effects health benefits, and immunological effect of Nigella sativa in children with beta thalassemia major.

Evaluate the extent of clinical improvement, reductions in serum iron and ferritin, antioxidant status, treatment of the causes of hemolysis and other therapeutic benefits of Nigella sativa in those patient.
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Nigella Sativa With Beta Thalassemia Major
Intervention  ICMJE Drug: nigella sativ
nigella sativa powder (2 gm/day) for 3 consecutive months.
Study Arms  ICMJE
  • Active Comparator: patients receiving Nigella
    40 patients in the treatment group that will receive nigella sativa powder (2 gm/day) for 3 consecutive months.
    Intervention: Drug: nigella sativ
  • No Intervention: patients not received nigella as controls
    40 patients in the control group will not receive nigella sativa and continued on the usual chelators
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 26, 2016)		 80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2017
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Thalassemia with iron overload

Exclusion Criteria:

  • Thalassemia complicated with diabetes mellitus or hepatitis
  • Patients who discontinue treatment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02816957
Other Study ID Numbers  ICMJE 30794l03l16
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Tanta University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Tanta University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mohamed Ramadan ELshanshory, prof professor of pediatrics
PRS Account Tanta University
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP