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Efficacy of Yinzhihuang Oral Liquid on Indirect Bilirubin of Neonates With Glucose-6-phosphate Dehydrogenase Deficiency

NCT02594904 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2015-11-03

No results posted yet for this study

Summary

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.

Conditions

  • Neonatal Hyperbilirubinemia

Interventions

DRUG

Yinzhihuang Oral Liquid

All the four groups will be given same treatment as being described in arm description.

Sponsors & Collaborators

  • Southern Medical University, China

    lead OTHER

Principal Investigators

  • Weimin Huang, Ph.D · The South Hospital of Southern Medical University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Days
Max Age
7 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2016-04-30
Completion
2016-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02594904 on ClinicalTrials.gov