Benefits of Nigella Sativa in Children With Beta Thalassemia Major

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

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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