Benefits of Nigella Sativa in Children With Beta Thalassemia Major

Nigella Sativa With Beta Thalassemia Major Clinical Trial

— Nigella  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02816957
• Other study ID #: 30794l03l16
• Status: Recruiting
• Phase: Early Phase 1
• First received: June 23, 2016
• Last updated: April 24, 2017
• Start date: June 2016
• Est. completion date: June 2017

Study information

• Verified date: June 2016
• Source: Tanta University
• Contact: Nahed Mohamed Habas, MD
• Phone: 01010560350
• Email: nahedhablas79[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

Inclusion Criteria:

• Thalassemia with iron overload

Exclusion Criteria:

• Thalassemia complicated with diabetes mellitus or hepatitis

• Patients who discontinue treatment

Related Conditions & MeSH terms

• beta-Thalassemia
• Nigella Sativa With Beta Thalassemia Major
• Thalassemia

Intervention

Drug:
• nigella sativ
nigella sativa powder (2 gm/day) for 3 consecutive months.

Locations

Country	Name	City	State
Egypt	Faculty of Medicine- Tanta University	Tanta	Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	malondialdehyde	nmol serum level of malondialdehyde (nmol per liter)	3 months
Primary	cluster of differentation4 and 8(CD4 and CD8)	CD4 and CD8 cell per cmm	3 months
Primary	total antioxidant	total antioxidant(mmol per liter)	3 months
Secondary	Serum iron	microgram per dl	3 months
Secondary	total iron binding capacity	microgram per dl	3 months
Secondary	serum ferritin	ng per ml	3 months
Secondary	complete blood count	complete blood count	3 months