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

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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

Brief Summary:
Evaluate the therapeutic effects health benefits, and immunological effect of Nigella sativa in children with beta thalassemia major.

Condition or disease Intervention/treatment Phase
Nigella Sativa With Beta Thalassemia Major Drug: nigella sativ Early Phase 1

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Study of The Therapeutic Benefits of Nigella Sativa in Children With Beta Thalassemia Major
Study Start Date : June 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thalassemia

Arm Intervention/treatment
Active Comparator: patients receiving Nigella
40 patients in the treatment group that will receive nigella sativa powder (2 gm/day) for 3 consecutive months.
Drug: nigella sativ
nigella sativa powder (2 gm/day) for 3 consecutive months.

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



Primary Outcome Measures :
  1. malondialdehyde [ Time Frame: 3 months ]
    nmol serum level of malondialdehyde (nmol per liter)

  2. cluster of differentation4 and 8(CD4 and CD8) [ Time Frame: 3 months ]
    CD4 and CD8 cell per cmm

  3. total antioxidant [ Time Frame: 3 months ]
    total antioxidant(mmol per liter)


Secondary Outcome Measures :
  1. Serum iron [ Time Frame: 3 months ]
    microgram per dl

  2. total iron binding capacity [ Time Frame: 3 months ]
    microgram per dl

  3. serum ferritin [ Time Frame: 3 months ]
    ng per ml

  4. complete blood count [ Time Frame: 3 months ]
    complete blood count



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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Thalassemia with iron overload

Exclusion Criteria:

  • Thalassemia complicated with diabetes mellitus or hepatitis
  • Patients who discontinue treatment

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): NCT02816957


Contacts
Contact: Nahed Mohamed Habas, MD 01010560350 nahedhablas79@gmail.com
Contact: Nahed moh Hablas, MD 00201010560350 nahedhabls79@gmail.com

Locations
Egypt
Faculty of Medicine- Tanta University Recruiting
Tanta, Gharbia, Egypt, 0000
Contact: Mohamed R El-Shanshory, MD    +201005680834    elshanshory@gmail.com   
Contact: Nahed M Hablas, MD    +201010560350    nahedhablas79@gmail.com   
Principal Investigator: Mohamed M El-Shanshory, MD         
Principal Investigator: Nahed AR Hablas, MD         
Principal Investigator: Salah M El Sayed, MD         
Sponsors and Collaborators
Tanta University
Investigators
Study Director: Mohamed Ramadan ELshanshory, prof professor of pediatrics

Responsible Party: Tanta University
ClinicalTrials.gov Identifier: NCT02816957     History of Changes
Other Study ID Numbers: 30794l03l16
First Posted: June 29, 2016    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Thalassemia
beta-Thalassemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn