A Phase 2/3 interventional study of Antox tablets(Mepaco) and drug therapy for ITP in Immune Thrombocytopenia, sponsored by Ain Shams University. Status unknown at 1 site in Egypt. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2013-01-09.
Sponsored by Ain Shams University · Phase 2/3, Interventional, and Treatment
Oxidative stress occurs as a result of increased activity of free radical-producing enzymes, decreased activity of free radical-removing enzymes, and insufficient levels of antioxidants. The most sensitive molecules to oxidation are lipids. Loss of cell membrane elasticity, increased cell fragility, and a shortened cellular life span results from oxidation of cell membrane lipids.
Free oxygen radicals may have an effect on the structural and functional damage of platelets and plays a role in pathogenesis of thrombocytopenia in both, acute and chronic ITP.
Selenium is an essential mineral found in small amounts in the body. It works as an antioxidant, especially when combined with other antioxidants as vitamin E , A and C. Antioxidants neutralize free radicals and may reduce or even help prevent some of the damage they cause.
aim of this study is to assess oxidant and antioxidant systems initially in patients with acute and chronic immune thrombocytopenia (ITP) and 6 months later.Another aim of the study is to evaluate effect of antioxidant therapy on bleeding score, platelet count and antioxidant status during 6 months follow-up.
697 studies on the registry are indexed under Thrombocytopenia; 153 are open to participants now.
This study's planned enrollment of 100 is above the median of 55 across 472 interventional studies indexed under Thrombocytopenia.
Browse Thrombocytopenia studies →Ain Shams University is the lead sponsor of 1,879 studies on the registry; 424 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
All patients less than 18 years with primary ITP; at initial presentation with platelet count less than 40 x 109/L attended Ain Shams Hematology clinic Children hospital from January 2013 and followed-up for 6 months.
Exclusion Criteria:
interventional arm 1 and will receive antioxidant therapy (Antox tablets ( 1 tablet contains : Vit. A 2000 IU, Vit C 90 mg, Vit E 15 mg and selenium yeast 55 ug ) with the therapy selected for ITP tailored according to patient's presentation.For Antox tablets it will be given daily for 6 months.
Drug: Antox tablets(Mepaco) · Other: drug therapy for ITP
drug therapy for ITP according to ASH, 2011 guidelines.
Other: drug therapy for ITP
effect of antioxidant on disease outcome
Also known as: antioxidant drug
drugs will be selected according to ASH,2011 guidelines
Also known as: dexamethasone, prednisolone, solumedrol, Anti-D, intravenous immunoglobulin, romioplastin
oxidant status in ITP
oxidant and antioxidant systems initially in patients with acute and chronic immune thrombocytopenia (ITP)
Time frame: 6 month
antioxidant therapy
antioxidant therapy on bleeding score, platelet count and antioxidant status
Time frame: 6 months
This study is status unknown, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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Ain Shams University