UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010377 |
|---|---|
| Receipt number | R000010891 |
| Scientific Title | Therapeutic effect of jizusoippo for symptoms of Yusho patients exposed to dioxins |
| Date of disclosure of the study information | 2013/04/15 |
| Last modified on | 2021/04/07 10:02:11 |
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Basic information
Public title
Therapeutic effect of jizusoippo for symptoms of Yusho patients exposed to dioxins
Acronym
Effect of jizusoippo for Yusho
Scientific Title
Therapeutic effect of jizusoippo for symptoms of Yusho patients exposed to dioxins
Scientific Title:Acronym
Effect of jizusoippo for Yusho
Region
| Japan |
Condition
Condition
Yusho disease
Classification by specialty
| Medicine in general | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of Jizusoippo on the symptoms of Yusho.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
respiratory, skin, and neurological symptoms, general fatigue, and QOL
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients take 2.5g of Jizusoippo three times a day after each meal for 6months.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 20 years or older who fulfilled the diagnostic criteria for Yusho established by the National Study Group for the Therapy of Yusho and give their written informed consents are eligible.
Key exclusion criteria
Patients are not eligible if they have serious diseases (malignant neoplasms, hepatic disorders, renal disorders, or blood disorders), have been treated with any other Kampo formulae, or are women with pregnancy or nursing women. Patients who are judged to have an ineligible health condition by medical doctors are excluded.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masutaka Furue |
Organization
Kyushu University Hospital
Division name
Dermatology
Zip code
Address
3-1-1, Maidashi, Higashiku, Fukuoka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Uchi |
Organization
Kyushu University Hospital
Division name
Research and Clinical Center for Yusho
Zip code
Address
3-1-1, Maidashi, Higashiku, Fukuoka
TEL
092-642-5211
Homepage URL
Sponsor or person
Institute
Kyushu University Hospital
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 10 | Month | 11 | Day |
Date of IRB
| 2012 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2013 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 01 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 01 | Day |
Last modified on
| 2021 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010891
