![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
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 |
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 |
|
Condition | |||
Condition | Certified Yusho victim | ||
Classification by specialty |
|
||
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 |
|
|
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 |
|
|||
Age-upper limit |
|
|||
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 |
|
||||||
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 |
|
||||||
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 | |
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 | |
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 |
|
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 |
|
||||||
Date of IRB | |||||||
Anticipated trial start date |
|
||||||
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 |
|
||||||
Last modified on |
|
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 |