Benefits of Nigella Sativa in Children With Beta Thalassemia Major

Early Phase 1

• Conditions: Nigella Sativa With Beta Thalassemia Major
• Interventions: Drug: nigella sativ

• Registration Number: NCT02816957
• Lead Sponsor: Tanta University

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.

Study Timeline

• Status Verified: 2016-06
• Study Start: 2016-06
• Study First Submitted: 2016-06-23
• Study First Submitted QC: 2016-06-26
• Study First Posted: 2016-06-29
• Last Update Submitted: 2017-04-24
• Last Update Posted: 2017-04-26
• Primary Completion: 2017-06
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Thalassemia with iron overload

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patients receiving Nigella	nigella sativ	40 patients in the treatment group that will receive nigella sativa powder (2 gm/day) for 3 consecutive months.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
total iron binding capacity	3 months	microgram per dl
Serum iron	3 months	microgram per dl
serum ferritin	3 months	ng per ml
complete blood count	3 months	complete blood count

Trial Locations

Locations (1)

Faculty of Medicine- Tanta University; 🇪🇬 Tanta, Gharbia, Egypt