Benefits of Nigella Sativa in Children With Beta Thalassemia Major (Nigella)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02816957|
Recruitment Status : Unknown
Verified June 2016 by Tanta University.
Recruitment status was: Recruiting
First Posted : June 29, 2016
Last Update Posted : April 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Nigella Sativa With Beta Thalassemia Major||Drug: nigella sativ||Early Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Study of The Therapeutic Benefits of Nigella Sativa in Children With Beta Thalassemia Major|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||June 2017|
Active Comparator: patients receiving Nigella
40 patients in the treatment group that will receive nigella sativa powder (2 gm/day) for 3 consecutive months.
Drug: nigella sativ
nigella sativa powder (2 gm/day) for 3 consecutive months.
No Intervention: patients not received nigella as controls
40 patients in the control group will not receive nigella sativa and continued on the usual chelators
- malondialdehyde [ Time Frame: 3 months ]nmol serum level of malondialdehyde (nmol per liter)
- cluster of differentation4 and 8(CD4 and CD8) [ Time Frame: 3 months ]CD4 and CD8 cell per cmm
- total antioxidant [ Time Frame: 3 months ]total antioxidant(mmol per liter)
- Serum iron [ Time Frame: 3 months ]microgram per dl
- total iron binding capacity [ Time Frame: 3 months ]microgram per dl
- serum ferritin [ Time Frame: 3 months ]ng per ml
- complete blood count [ Time Frame: 3 months ]complete blood count
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02816957
|Contact: Nahed Mohamed Habas, MDfirstname.lastname@example.org|
|Contact: Nahed moh Hablas, MDemail@example.com|
|Faculty of Medicine- Tanta University||Recruiting|
|Tanta, Gharbia, Egypt, 0000|
|Contact: Mohamed R El-Shanshory, MD +201005680834 firstname.lastname@example.org|
|Contact: Nahed M Hablas, MD +201010560350 email@example.com|
|Principal Investigator: Mohamed M El-Shanshory, MD|
|Principal Investigator: Nahed AR Hablas, MD|
|Principal Investigator: Salah M El Sayed, MD|
|Study Director:||Mohamed Ramadan ELshanshory, prof||professor of pediatrics|