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

Primary Purpose

Nigella Sativa With Beta Thalassemia Major

Status
Unknown status
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
nigella sativ
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nigella Sativa With Beta Thalassemia Major

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Thalassemia with iron overload

Exclusion Criteria:

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

Sites / Locations

  • Faculty of Medicine- Tanta UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

patients receiving Nigella

patients not received nigella as controls

Arm Description

40 patients in the treatment group that will receive nigella sativa powder (2 gm/day) for 3 consecutive months.

40 patients in the control group will not receive nigella sativa and continued on the usual chelators

Outcomes

Primary Outcome Measures

malondialdehyde
nmol serum level of malondialdehyde (nmol per liter)
cluster of differentation4 and 8(CD4 and CD8)
CD4 and CD8 cell per cmm
total antioxidant
total antioxidant(mmol per liter)

Secondary Outcome Measures

Serum iron
microgram per dl
total iron binding capacity
microgram per dl
serum ferritin
ng per ml
complete blood count
complete blood count

Full Information

First Posted
June 23, 2016
Last Updated
April 24, 2017
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT02816957
Brief Title
Benefits of Nigella Sativa in Children With Beta Thalassemia Major
Acronym
Nigella
Official Title
Study of The Therapeutic Benefits of Nigella Sativa in Children With Beta Thalassemia Major
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tanta University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nigella Sativa With Beta Thalassemia Major

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patients receiving Nigella
Arm Type
Active Comparator
Arm Description
40 patients in the treatment group that will receive nigella sativa powder (2 gm/day) for 3 consecutive months.
Arm Title
patients not received nigella as controls
Arm Type
No Intervention
Arm Description
40 patients in the control group will not receive nigella sativa and continued on the usual chelators
Intervention Type
Drug
Intervention Name(s)
nigella sativ
Intervention Description
nigella sativa powder (2 gm/day) for 3 consecutive months.
Primary Outcome Measure Information:
Title
malondialdehyde
Description
nmol serum level of malondialdehyde (nmol per liter)
Time Frame
3 months
Title
cluster of differentation4 and 8(CD4 and CD8)
Description
CD4 and CD8 cell per cmm
Time Frame
3 months
Title
total antioxidant
Description
total antioxidant(mmol per liter)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Serum iron
Description
microgram per dl
Time Frame
3 months
Title
total iron binding capacity
Description
microgram per dl
Time Frame
3 months
Title
serum ferritin
Description
ng per ml
Time Frame
3 months
Title
complete blood count
Description
complete blood count
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Thalassemia with iron overload Exclusion Criteria: Thalassemia complicated with diabetes mellitus or hepatitis Patients who discontinue treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nahed Mohamed Habas, MD
Phone
01010560350
Email
nahedhablas79@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nahed moh Hablas, MD
Phone
00201010560350
Email
nahedhabls79@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Ramadan ELshanshory, prof
Organizational Affiliation
professor of pediatrics
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Medicine- Tanta University
City
Tanta
State/Province
Gharbia
ZIP/Postal Code
0000
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed R El-Shanshory, MD
Phone
+201005680834
Email
elshanshory@gmail.com
First Name & Middle Initial & Last Name & Degree
Nahed M Hablas, MD
Phone
+201010560350
Email
nahedhablas79@gmail.com
First Name & Middle Initial & Last Name & Degree
Mohamed M El-Shanshory, MD
First Name & Middle Initial & Last Name & Degree
Nahed AR Hablas, MD
First Name & Middle Initial & Last Name & Degree
Salah M El Sayed, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Benefits of Nigella Sativa in Children With Beta Thalassemia Major

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