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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017463
Receipt No. R000020241
Scientific Title Clinical Investigation of Keisi-bukuryogan for the treatment of symptoms in Yusho patients.
Date of disclosure of the study information 2015/05/18
Last modified on 2016/05/09

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Basic information
Public title Clinical Investigation of Keisi-bukuryogan for the treatment of symptoms in Yusho patients.
Acronym Clinical Investigation of Keisi-bukuryogan in Yusho patients.
Scientific Title Clinical Investigation of Keisi-bukuryogan for the treatment of symptoms in Yusho patients.
Scientific Title:Acronym Clinical Investigation of Keisi-bukuryogan in Yusho patients.
Region
Japan

Condition
Condition Certified Yusho victim
Classification by specialty
Medicine in general Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of Keisi-bukuryogan on various symptoms with open-label, one-arm study in patients with Yusho. In addition, the effect on QOL improvement and the influence on oxidative stress are investigated.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes VAS score (peripheral nerve: pain, numbness, skin; acne, blotch, respiratory; cough, sputum, malaise)
Key secondary outcomes 1. QOL (Quality Of Life) quantitatively evaluated by SF-36.
2. Oxidative stress marker value s and anti-oxidative stress marker values.
1. Safety during treatment period.

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 2.5 g of Keisi-bukuryogan (Tsumura) is administered t.i.d every before or between meals until 3 months after the enrollment.
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 1) Patients diagnosed as Yusho according to Yusho diagnostic criteria, the Study Group for "Yusho".
2) Patients providing written informed consent.
3) Patients who are able to take Kampo medicine.
4) Patients with more than 20 years.
Key exclusion criteria 1) Women who have pregnancy, are nursing, or are likely to become pregnant.
2) Patients who are taking other Kampo medicines. Patients who have 4 weeks washout period for attending the study are eligible.
3) Any other patients who are regarded as unsuitable for this study by the investigators because of such as serious complication.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masutaka Furue
Organization Graduate School of Medical Sciences, Kyushu University
Division name Department of Dermatology
Zip code
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka, Fukuoka 812-8582, Japan
TEL 092-642-5581
Email furue@dermatol.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chikage Mitoma
Organization Kyushu University Hospital
Division name Research and Clinical Center for Yusho and Dioxin
Zip code
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka, Fukuoka 812-8582, Japan
TEL 092-642-5211
Homepage URL
Email mchikage@dermatol.med.kyushu-u.ac.jp

Sponsor
Institute Department of Dermatology, Graduate School of Medical Sciences, Kyushu University
Institute
Department

Funding Source
Organization MHLW
Organization
Division
Category of Funding Organization Japanese Governmental office
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 九州大学病院(福岡県)、五島中央病院(長崎県)

Other administrative information
Date of disclosure of the study information
2015 Year 05 Month 18 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
2015 Year 05 Month 11 Day
Date of IRB
Anticipated trial start date
2015 Year 05 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 05 Month 08 Day
Last modified on
2016 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020241

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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