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Main
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Note: This record shows only the 20 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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JPRN |
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Last refreshed on:
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27 May 2013 |
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Main ID: |
JPRN-C000000276 |
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Date of registration:
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01/01/2008 |
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Primary sponsor: |
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Public title:
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A controlled trial of zinc supplementation for decompensated liver cirrhosis
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Scientific title:
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Date of first enrolment:
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2005/12/01 |
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Target sample size:
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90 |
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Recruitment status: |
Completed |
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URL:
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http://www.umin.ac.jp/ctr/index.htm |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Countries of recruitment
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Japan
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Contacts
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Name:
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Address:
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Japan |
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Telephone:
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Email:
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takuma@enjoy.ne.jp |
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Affiliation:
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NHO IwakuniClinical Center Department of Internal Medicine |
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Name:
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Address:
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Japan |
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Telephone:
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takuma@enjoy.ne.jp |
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Email:
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takuma@enjoy.ne.jp |
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Affiliation:
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NHO IwakuniClinical Center Department of Internal Medicine |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1.Decompensated liver cirrhosis more than 12 weeks during BCAA granule administration,and hyperammonemia(more than 50 micromol/l).
2.hepatic encephalopathy is present.
or the anamnestic patient (decompensated liver cirrhosis).
3.The prognosis obtained more than one year.
4.Age is within 20-80 years old
5.For patients with HCC the Milan criteria are applied (solitary tumor of less than 5 cm, or three or fewer lesions, none more than 3 cm without vascular invasion, or extrahepatic metastasis), and patients were to undergo potentially curative treatments with percutaneous ethanol injection therapy, combined with transcatheter arterial embolization, radiofrequency ablation therapy, or surgical resection.
6.We do not ask whether hospitalization or outpatient.
7.The patient is obtained an agreement by a document.
Exclusion criteria: 1.The patient with pregnancy or gravid possibility.
2.Advanced HCC, or other malignancy, its prognosis is less than 1 year.
3.Less than 2.5g/ml of serum albumin level
4.More than 3.0mg/dl of total bil.
5.Hepatic encephalopathy (possible anamnestic case) is higher than 3 degree.
6. The patients whom judged to be inadequate by clinical trial liability or clinical trial allotment doctor.
Age minimum:
20years-old
Age maximum:
80years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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decompensated liver cirrhosis
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Intervention(s)
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oral zinc supplementation + BCAA granule
only BCAA granule
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Primary Outcome(s)
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QOL(SF-36)
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Source(s) of Monetary Support
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NHO IwakuniClinical Center
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