Clinical trial NCT04292314: Hydroxy Urea, Omega 3, Nigella Sativa,Honey on Oxidative Stress and Iron Chelation in Pediatric Major Thalassemia
Official title: Impact of Combination Therapy Between Hydroxy Urea, Omega 3, Nigella Sativa and Honey on Antioxidant-oxidant Status and Reduction of Iron Overload in Pediatric Major Thalassemia
Conditions: Iron Overload
Oxidative Stress
Thalassemia Major
Summary: The aim of the present study is evaluating the strength of combination therapy of hydroxy urea, omega 3, nigella sativa and honey on antioxidant-oxidant status (OXIDATIVE STRESS) in response to reactive oxygen species production (LIPID PEROXIDATION) and their effect on iron intoxication (IRON CHELATION) in pediatric major thalassemia.
Interventions:
description: Omega-3 supplementation (300-400mg EPA & 200-300mg DHA) per day for 8 consecutive months up to 10 months
name: Omega 3
type: Drug
description: Nigella sativa supplementation (1g black seed oil contain 1% thymoquinone) per day for 8 consecutive months up to 10 months
name: Nigella Sativa Oil
type: Drug
description: hydroxyurea medication (5 to 15mg/kg) per day for 8 consecutive months up to 10 months.
name: Hydroxyurea
type: Drug
description: Natural honey(2.5 mg/kg dissolved in 250 ml water) per day for 8 consecutive months up to 10 months.
name: Honey
other_name: Natural honey formulation
type: Drug
description: deferoxamine (SubQ infusion: 20 to 40 mg/kg/day over 8 to 12 hours, 6 to 7 nights per week, maximum daily dose: 40 mg/kg/day)for 8 consecutive months up to 10 months.
name: Deferoxamine
type: Drug
description: Regular blood transfusion session based on patient hematological profile starts from one session every 2 weeks.
name: blood transfusion session
type: Procedure
Study arms:
design_group_description: 50 patients from each participating hospital that will receive Omega-3 supplementation (300-400mg EPA & 200-300mg DHA) per day for 8 consecutive months up to 10 months.<br/>in addition to experimental treatment this group will receive the traditional treatment of deferoxamine/deferasirox plus regular blood transfusion with dose de-escalation methods till efficacy of experimental treatment proved.
design_group_title: Omega-3 experimental group
design_group_type: Experimental
design_group_description: 50 patients from each participating hospital that will receive Nigella sativa supplementation (1g black seed oil contain 1% thymoquinone) per day for 8 consecutive months up to 10 months.<br/>in addition to experimental treatment this group will receive the traditional treatment of deferoxamine/deferasirox plus regular blood transfusion with dose de-escalation methods till efficacy of experimental treatment proved.
design_group_title: Nigella sativa experimental group
design_group_type: Experimental
design_group_description: 50 patients from each participating hospital that will receive hydroxyurea medication (5 to 15mg/kg) per day for 8 consecutive months up to 10 months.<br/>in addition to the experimental treatment, this group will receive the traditional treatment of deferoxamine/deferasirox plus regular blood transfusion with dose de-escalation methods until the efficacy of experimental treatment proved.
design_group_title: Hydroxyurea experimental group
design_group_type: Experimental
design_group_description: 50 patients from each participating hospital that will receive natural honey(2.5 mg/kg dissolved in 250 ml water) per day for 8 consecutive months up to 10 months.<br/>in addition to the experimental treatment, this group will receive the traditional treatment of deferoxamine/deferasirox plus regular blood transfusion with dose de-escalation methods until the efficacy of experimental treatment proved.
design_group_title: Natural honey experimental group
design_group_type: Experimental
design_group_description: 50 patients from each participating hospital that will receive the ordinary treatment of iron chelator agent of deferoxamine or deferasirox (SubQ infusion: 20 to 40 mg/kg/day over 8 to 12 hours, 6 to 7 nights per week, maximum daily dose: 40 mg/kg/day)for 8 consecutive months up to 10 months.<br/>in addition to iron chelator agent, this group receive regular blood transfusion session.
design_group_title: Ordinary hospital treatment group
design_group_type: Active Comparator
Sponsor: Beni-Suef University
Collaborators: University of Arizona
Drug name mappings:
name: ω-3酸乙酯(Trygg Pharma AS)
lang: CN
name: Omega-3-acid ethyl esters(Trygg Pharma AS)
lang: EN
name: 甲磺酸去铁胺
lang: CN
name: Deferoxamine Mesylate
lang: EN
name: デフェロキサミンメシル酸塩
lang: JP
name: 羟基脲
lang: CN
name: Hydroxycarbamide
lang: EN
name: ヒドロキシカルバミド
lang: JP