Benefits of Nigella Sativa in Children With Beta Thalassemia Major

T

Tanta University

Status and phase

Unknown
Early Phase 1

Conditions

Nigella Sativa With Beta Thalassemia Major

Treatments

Drug: nigella sativ

Study type

Interventional

Funder types

Other

Identifiers

NCT02816957
30794l03l16

Details and patient eligibility

About

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

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

3 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Thalassemia with iron overload

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

80 participants in 2 patient groups

patients receiving Nigella
Active Comparator group
Description:
40 patients in the treatment group that will receive nigella sativa powder (2 gm/day) for 3 consecutive months.
Treatment:
Drug: nigella sativ
patients not received nigella as controls
No Intervention group
Description:
40 patients in the control group will not receive nigella sativa and continued on the usual chelators

Trial contacts and locations

0

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Central trial contact

Nahed Mohamed Habas, MD; Nahed moh Hablas, MD

Data sourced from clinicaltrials.gov

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