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A Multicenter Study to Evaluate the Efficacy of Yinzhihuang Oral Liquid on Indirect Bilirubin of Neonates With Glucose-6-phosphate Dehydrogenase Deficiency
Neonatal Glucose-6-phosphate Dehydrogenase(G6PD) Deficiency is one of the significant reason for neonatal hyperbilirubinemia and even irreversible bilirubin encephalopathy.The neonates may be attacked due to acute infection, eating beans or exposure to oxidative drugs, etc. The main clinical manifestations are hemolytic anemia, and the resulting hyperbilirubinemia. When bilirubin is pretty high in body, bilirubin may spread into brain, and thus cause nervous system damage, and severely affect the prognosis of neonates. Therefore, monitoring and early intervention of jaundice has important significance to prevent further aggravation of jaundice and certain sequelae. Phototherapy and exchange transfusion are mainly suitable methods for severe hyperbilirubinemia, however, patients need to be hospitalized. Yinzhihuang Oral Liquid is a kind of traditional Chinese medicine for jaundice. Many large sample and multicenter clinical studies show that the positive efficacy of Yinzhihuang Oral Liquid in the treatment of neonatal hyperbilirubinemia is exactly confirmed. The purpose of this study is try to detect the treatment effect of Yinzhihuang Oral Liquid on indirect bilirubin in neonates with G-6-PD enzyme deficiency and neonatal hyperbilirubinemia. Try to provide scientific theories for Yinzhihuang Oral Liquid to treat neonates with G-6-PD enzyme deficiency and neonatal hyperbilirubinemia.
Details
| Lead sponsor | Southern Medical University, China |
|---|---|
| Phase | Phase 4 |
| Status | UNKNOWN |
| Enrolment | 300 |
| Start date | 2015-07 |
| Completion | 2016-06 |
Conditions
- Neonatal Hyperbilirubinemia
Interventions
- Yinzhihuang Oral Liquid
Primary outcomes
- The change(umol/L) from baseline of total bilirubin(umol/L) will be calculated and finalized — Every 24 hours during dosing, for around three days.(Typicall the dosing will be stopped once the bilirubin is below 100umol/L)
Value of the total bilirubin in serum(umol/L) will be collected and calculated.
Countries
China