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

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ClinicalTrials.gov Identifier: NCT02594904
Recruitment Status : Unknown
Verified October 2015 by Weimin Huang, Southern Medical University, China.
Recruitment status was:  Recruiting
First Posted : November 3, 2015
Last Update Posted : November 3, 2015
Sponsor:
Information provided by (Responsible Party):
Weimin Huang, Southern Medical University, China

Brief 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.


Condition or disease Intervention/treatment Phase
Neonatal Hyperbilirubinemia Drug: Yinzhihuang Oral Liquid Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Study to Evaluate the Efficacy of Yinzhihuang Oral Liquid on Indirect Bilirubin of Neonates With Glucose-6-phosphate Dehydrogenase Deficiency
Study Start Date : July 2015
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : June 2016


Arm Intervention/treatment
Experimental: G-6-PD normal group
Drug: Yinzhihuang Oral Liquid, dose: 3ml each time, 3 times every day, during the period, measuring bilirubin from skin one time every 24 hours.
Drug: Yinzhihuang Oral Liquid
All the four groups will be given same treatment as being described in arm description.
Other Name: Huarun Yinzhihuang Oral solution

Experimental: G-6-PD mild deficiency group
Drug: Yinzhihuang Oral Liquid, dose: 3ml each time, 3 times every day, during the period, measuring bilirubin from skin one time every 24 hours.
Drug: Yinzhihuang Oral Liquid
All the four groups will be given same treatment as being described in arm description.
Other Name: Huarun Yinzhihuang Oral solution

Experimental: G-6-PD moderate deficiency group
Drug: Yinzhihuang Oral Liquid, dose: 3ml each time, 3 times every day, during the period, measuring bilirubin from skin one time every 24 hours.
Drug: Yinzhihuang Oral Liquid
All the four groups will be given same treatment as being described in arm description.
Other Name: Huarun Yinzhihuang Oral solution

Experimental: G-6-PD sever deficiency group
Drug: Yinzhihuang Oral Liquid, dose: 3ml each time, 3 times every day, during the period, measuring bilirubin from skin one time every 24 hours.
Drug: Yinzhihuang Oral Liquid
All the four groups will be given same treatment as being described in arm description.
Other Name: Huarun Yinzhihuang Oral solution




Primary Outcome Measures :
  1. The change(umol/L) from baseline of total bilirubin(umol/L) will be calculated and finalized [ Time Frame: 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.


Secondary Outcome Measures :
  1. The percent change(%) from baseline of total bilirubin(umol/L) will be calculated and finalized [ Time Frame: 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.



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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Full-term newborns with jaundice after 3-7 days of birth, total bilirubin in serum or transcutaneous bilirubin is between 100umol/L and 257umol/L, and start taking Yinzhihuang oral liquid, dose: 3ml per each time, 3 times per each day, during the period, measuring bilirubin from skin one time every 24 hours;
  2. Gestational age≥37 weeks, birth weight≥2.5Kg, Apgar scores≥8;
  3. lineal consanguinity are all the native residents from Guangdong or Guangxi;
  4. The enzyme activity of G-6-PD will be detected and collected from all the neonates subjects;
  5. Informed consents of all the neonates subjects are needed.

Note: Icterus testers are Minolta 105 type. Measurements of bilirubin are from three location, inluding forehead, chest and abdomen. The value of bilirubin will use the average value from the three location, and the unit is umol / L.

Exclusion Criteria:

  1. Neonates with inherited metabolic diseases;
  2. Neonates with congenital malformation of liver and gallbladder;
  3. Neonates with asphyxia, hypoxia, acidosis, sepsis, high fever, low temperature, low protein, low blood sugar, etc. which may lead to bilirubin encephalopathy;
  4. History of oxidation drug exposure(e.g. honeysuckle bath)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02594904


Contacts
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Contact: Weimin Huang, Ph.D +8613900261113 drhwm2003@hotmail.com

Locations
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China, Guangdong
The South Hospital of Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Weimin Huang, Ph.D    13900261113    drhwm2003@hotmail.com   
Sponsors and Collaborators
Southern Medical University, China
Investigators
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Principal Investigator: Weimin Huang, Ph.D The South Hospital of Southern Medical University

Publications:
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Responsible Party: Weimin Huang, Chief physician, Southern Medical University, China
ClinicalTrials.gov Identifier: NCT02594904     History of Changes
Other Study ID Numbers: whuang201500601
First Posted: November 3, 2015    Key Record Dates
Last Update Posted: November 3, 2015
Last Verified: October 2015
Keywords provided by Weimin Huang, Southern Medical University, China:
G6PD Deficiency
Neonatal Hyperbilirubinemia
Yinzhihuang Oral Liquid
Indirect Bilirubin
Additional relevant MeSH terms:
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Glucosephosphate Dehydrogenase Deficiency
Hyperbilirubinemia, Neonatal
Hyperbilirubinemia
Pathologic Processes
Infant, Newborn, Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Genetic Diseases, Inborn
Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Metabolic Diseases
Bilirubin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs