UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical Investigation of Keisi-bukuryogan for the treatment of symptoms in Yusho patients.
Title of the study (Brief title)	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.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Masutaka Furue
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Dermatology
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	Chikage Mitoma
Organization	Kyushu University Hospital
Division name	Research and Clinical Center for Yusho and Dioxin
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 05 Month 11 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000020241