UMIN-CTR Clinical Trial

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
Email

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
Email

Sponsor
Institute	Kyushu University Hospital
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010891