drugset / Trial / NCT04292314
Hydroxy Urea, Omega 3, Nigella Sativa,Honey on Oxidative Stress and Iron Chelation in Pediatric Major Thalassemia
Phase 2/3
Completed
350 enrolled
Beni-Suef University
Beni-Suef Health insurance hospital · collabMaternity and Children Hospital, Makkah · collabUniversity of Arizona · collab
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2019-11-01
- Primary completion
- 2020-12-20
- Completion
- 2021-01-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Honey | Unknown | 2.5 mg/kg | — |
| Subject | Hydroxyurea | Other / unclassified | 5 mg/kg | — |
| Subject | Hydroxyurea | Other / unclassified | 15 mg/kg | — |
| Subject | Nigella Sativa Oil | Traditional medicine (herbal / TCM) | 1 g | — |
| Subject | Omega-3 fatty acids | Unknown | 200 mg | — |
| Subject | Omega-3 fatty acids | Unknown | 300 mg | — |
| Subject | Omega-3 fatty acids | Unknown | 400 mg | — |
| Background | Deferoxamine | Other / unclassified | 20 mg/kg | Subcutaneous |
| Background | Deferoxamine | Other / unclassified | 40 mg/kg | Subcutaneous |