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Evaluate the therapeutic effects health benefits, and immunological effect of Nigella sativa in children with beta thalassemia major.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients receiving Nigella | Active Comparator | 40 patients in the treatment group that will receive nigella sativa powder (2 gm/day) for 3 consecutive months. |
|
| patients not received nigella as controls | No Intervention | 40 patients in the control group will not receive nigella sativa and continued on the usual chelators |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nigella sativ | Drug | nigella sativa powder (2 gm/day) for 3 consecutive months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| malondialdehyde | nmol serum level of malondialdehyde (nmol per liter) | 3 months |
| cluster of differentation4 and 8(CD4 and CD8) | CD4 and CD8 cell per cmm | 3 months |
| total antioxidant | total antioxidant(mmol per liter) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Serum iron | microgram per dl | 3 months |
| total iron binding capacity | microgram per dl | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nahed Mohamed Habas, MD | Contact | 01010560350 | nahedhablas79@gmail.com | |
| Nahed moh Hablas, MD | Contact | 00201010560350 | nahedhabls79@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mohamed Ramadan ELshanshory, prof | professor of pediatrics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine- Tanta University | Recruiting | Tanta | Gharbia Governorate | 0000 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41877935 | Derived | Abdelshafy M, El Shanshory M, Shahat K, Al Jaouni SK, Attia M, Hamous SAA, Aboonq MS, Saad AA, Alayoubi AM, Bahashwan AS, Alhussaini AMT, Abdel-Latif HM, Albeihany AM, Hemdan SB, Yousef RS, Aloufi HA, Alsaedi AM, Alsaedi K, Eid RM, Mohamed N, Abdellah WA, Afifi TM, El Sayed SM, Hablas N. Immunological, hematological and biochemical benefits of adjuvant nigella sativa to pharmacotherapy in immune thrombocytopenic purpura patients. Am J Blood Res. 2026 Feb 15;16(1):1-13. doi: 10.62347/DBNQ6080. eCollection 2026. |
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| serum ferritin | ng per ml | 3 months |
| complete blood count | complete blood count | 3 months |