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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ITMCTR |
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Last refreshed on:
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20 February 2023 |
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Main ID: |
ITMCTR2100005205 |
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Date of registration:
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2021-08-26 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Clinical Study of Lidan Mixture on Children with Biliary Atresia after Hilar Jejunal Anastomosis
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Scientific title:
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Clinical Study of Lidan Mixture on Children with Biliary Atresia after Hilar Jejunal Anastomosis |
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Date of first enrolment:
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2019-04-01 |
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Target sample size:
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Control group:30;Therapy group:30; |
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Recruitment status: |
Recruiting |
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URL:
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http://itmctr.ccebtcm.org.cn/en-US/Home/ProjectView?pid=d6fc1cda-192d-4431-bcd6-7452b286620a |
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Study type:
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Interventional study |
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Study design:
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Parallel
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Phase:
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N/A
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Countries of recruitment
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China
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Contacts
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Name:
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Xiao-Li Xiong
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Address:
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100 Hong Kong Road, Jiang'an District, Wuhan, Hubei
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Telephone:
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+86 27 82433160 |
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Email:
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3112897691@qq.com |
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Affiliation:
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Name:
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Xiao-Li Xiong
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Address:
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100 Hong Kong Road, Jiang'an District, Wuhan, Hubei
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Telephone:
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+86 27 82433160 |
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Email:
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3112897691@qq.com |
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Affiliation:
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Wuhan Children's Hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Children with biliary atresia confirmed by surgery and pathology and undergoing Kasai surgery, aged < 120 days at the day of the first operation;
2. Can cooperate with the doctor's treatment and takes regular examinations;
3. The included patients were performed by Dr. Yan Xueqiang in the Department of General Surgery or Dr. Xiong Xiaofeng in the Department of Neonatal surgery.
Exclusion criteria: 1. Cirrhosis with intrahepatic calculi, portal hypertension, gastrointestinal bleeding and other serious complications;
2. Complicated with severe kidney, blood system, endocrine, cardiovascular, nervous system diseases;
3. Children with liver failure.
Age minimum:
0
Age maximum:
1
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Biliary atresia
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Intervention(s)
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Control group:Conventional antibiotics, ursodeoxycholic acid, hormones and Lidan Mixture;Therapy group:Conventional antibiotics, ursodeoxycholic acid, hormones;
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Primary Outcome(s)
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Serum type III procollagen;Kidney function (BUN, SCR, UA);Serum hyaluronidase;Liver function (ALT, AST, TBIL, DBIL, ?-GGT);Serum type IV collagen;Serum laminin;
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Secondary ID(s)
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ChiCTR2100050356
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ChiMCTR2100005205
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Source(s) of Monetary Support
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Hubei Provincial Health Commission Support Fund Project No. ZY2019M006
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Ethics review
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Status: Approved
Approval date: 15/10/2020
Contact:
Zhong Liang
+86 27 82438516
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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