Benefits of Nigella Sativa in Children With Beta Thalassemia Major

Study of The Therapeutic Benefits of Nigella Sativa in Children With Beta Thalassemia Major

Status

UNKNOWN

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02816957

Acronym

Nigella

Enrollment

Registered

2016-06-29

Start date

2016-06-30

Completion date

2017-06-30

Last updated

2017-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nigella Sativa 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.

Interventions

DRUGnigella sativ

nigella sativa powder (2 gm/day) for 3 consecutive months.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

3 Years to 18 Years

Healthy volunteers

Inclusion criteria

* Thalassemia with iron overload

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
malondialdehyde	3 months	nmol serum level of malondialdehyde (nmol per liter)
cluster of differentation4 and 8(CD4 and CD8)	3 months	CD4 and CD8 cell per cmm
total antioxidant	3 months	total antioxidant(mmol per liter)

Secondary

Measure	Time frame	Description
Serum iron	3 months	microgram per dl
complete blood count	3 months	complete blood count
total iron binding capacity	3 months	microgram per dl
serum ferritin	3 months	ng per ml

Countries

Egypt

Contacts

Primary ContactNahed Mohamed Habas, MD

nahedhablas79@gmail.com01010560350

Backup ContactNahed moh Hablas, MD

nahedhabls79@gmail.com00201010560350

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026