Unique ID issued by UMIN | UMIN000017463 |
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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 |
Clinical Investigation of Keisi-bukuryogan for the treatment of symptoms in Yusho patients.
Clinical Investigation of Keisi-bukuryogan in Yusho patients.
Clinical Investigation of Keisi-bukuryogan for the treatment of symptoms in Yusho patients.
Clinical Investigation of Keisi-bukuryogan in Yusho patients.
Japan |
Certified Yusho victim
Medicine in general | Dermatology |
Others
NO
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.
Safety,Efficacy
VAS score (peripheral nerve: pain, numbness, skin; acne, blotch, respiratory; cough, sputum, malaise)
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.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
2.5 g of Keisi-bukuryogan (Tsumura) is administered t.i.d every before or between meals until 3 months after the enrollment.
20 | years-old | <= |
Not applicable |
Male and Female
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.
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.
50
1st name | |
Middle name | |
Last name | Masutaka Furue |
Graduate School of Medical Sciences, Kyushu University
Department of Dermatology
3-1-1, Maidashi, Higashi-ku, Fukuoka, Fukuoka 812-8582, Japan
092-642-5581
furue@dermatol.med.kyushu-u.ac.jp
1st name | |
Middle name | |
Last name | Chikage Mitoma |
Kyushu University Hospital
Research and Clinical Center for Yusho and Dioxin
3-1-1, Maidashi, Higashi-ku, Fukuoka, Fukuoka 812-8582, Japan
092-642-5211
mchikage@dermatol.med.kyushu-u.ac.jp
Department of Dermatology, Graduate School of Medical Sciences, Kyushu University
MHLW
Japanese Governmental office
NO
九州大学病院(福岡県)、五島中央病院(長崎県)
2015 | Year | 05 | Month | 18 | Day |
Unpublished
Completed
2015 | Year | 05 | Month | 11 | Day |
2015 | Year | 05 | Month | 25 | Day |
2015 | Year | 05 | Month | 08 | Day |
2016 | Year | 05 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020241
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