UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017463 |
|---|---|
| Receipt number | 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 08:31:31 |
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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
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
mchikage@dermatol.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Dermatology, Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020241
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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