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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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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000016826 |
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Date of registration:
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31/03/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The evaluation of oxidative stress and the effect of pirfenidone in patients with idiopathic pulmonary fibrosis.
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Scientific title:
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The evaluation of oxidative stress and the effect of pirfenidone in patients with idiopathic pulmonary fibrosis. - The evaluation of oxidative stress and the effect of pirfenidone in patients with idiopathic pulmonary fibrosis. |
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Date of first enrolment:
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2015/03/31 |
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Target sample size:
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40 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019528 |
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Study type:
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Interventional |
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Study design:
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Parallel Non-randomized
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Phase:
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Not applicable
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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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SHUJI
OH-ISHI |
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Address:
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825 Terunuma, Tokai-mura, Naka-gun, Ibaraki 319-1113, Japan
319-1113
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Telephone:
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+81-29-282-1151 |
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Email:
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ooishi.shuji.dg@mail.hosp.go.jp |
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Affiliation:
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National Hospital Organization Ibarakihigashi National Hospital Department of Respiratory Medicine |
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Name:
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SHUJI
OH-ISHI |
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Address:
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825 Terunuma, Tokai-mura, Naka-gun, Ibaraki 319-1113, Japan
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Telephone:
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+81-29-282-1151 |
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Email:
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ooishi.shuji.dg@mail.hosp.go.jp |
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Affiliation:
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National Hospital Organization Ibarakihigashi National Hospital Department of Respiratory Medicine |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1. The patients who disagree with involving in this study. 2. The patients had taken oral steroid medication and immunosuppressive therapy. 3. The patients who diagnosed as respiratory disorders other than IPF, malignancy, overt cardiac failure, and hepatic and renal disease.
Age minimum:
Not applicable
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Idiopathic pulmonary fibrosis (IPF)
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Intervention(s)
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Pirfenidone
Observation
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Primary Outcome(s)
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Oxidative stress markers
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Secondary Outcome(s)
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Pulmonary function test, 6-minute walking test, St. George's Respiratory Questionnaire, Inflammatory cytokine, Incidence rate of acute exacerbation, Exacerbation-free survival time
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Source(s) of Monetary Support
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National Hospital Organization Ibarakihigashi National Hospital
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Ethics review
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Status: YES
Approval date: 29/01/2015
Contact:
yamano.yoichi.pn@mail.hosp.go.jp
Ibarakihigashi National Hospial
+81-29-282-1151
yamano.yoichi.pn@mail.hosp.go.jp
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Results
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Results available:
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Yes |
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Date Posted:
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23/04/2020 |
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Date Completed:
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31/03/2021 |
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URL:
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