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The present study will be carried on 60 children patients with β- thalassemia major attending The Hematology Unit of Paediatric Departments at Tanta University Hospital. Participants will divide into 3 groups:
Group 1: 20 patients receive Al-hijamah.
Group 2: 20 patients receive Al-hijamah plus iron chelation therapy.
Group 3: 20 patients receive iron chelation therapy only
Participants undergo:
Laboratory investigations:
CBC (complete blood count) of peripheral venous blood before Al-hijamah and daily after it.
Differences between CBC from venous blood and cupped blood (bloody excretion collected inside suction cups). Cupped blood is collected in heparin coated with and added to suction cups put on the skin surface.
• Serum iron and ferritin before Al-hijamah and after it.
• Serum iron and ferritin in cupped blood vs venous blood.
• Serum lipid profile and glycosylated hemoglobin before Al-hijamah and after it.
Assessment of heart function by Echocardiographic study (before and 3 month after Al-hijamah):
Technical steps of Al-hijamah (Necessary equipments are ready and can do it for all patients if possible):
Al-hijamah (Triple S technique under strict sterilization):
Study endpoint:
This study will be terminated if safety of the patient were in dangers due to elements related to the new therapeutic agent or if the treatment not proven efficacious.
Risks to participants are reasonable in relation to anticipated benefits. Many human studies have proven safety of Al-hijamah.
Compensations of controls for transportation or work absence and of patients for any injury, and if so, description of the compensation should be mentioned.
No, compensations.
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60 participants in 3 patient groups
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Central trial contact
Nahed Habas, MD; Mohammed El shanshoryR, Prof.
Data sourced from clinicaltrials.gov
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