Unique ID issued by UMIN | UMIN000021295 |
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Receipt number | R000024175 |
Scientific Title | Volumetric evaluation for venous malformation treated with a Japanese herbal medicine. |
Date of disclosure of the study information | 2016/03/16 |
Last modified on | 2019/03/26 08:40:43 |
Volumetric evaluation for venous malformation treated with a Japanese herbal medicine.
Japanese herbal medicine for venous malformation.
Volumetric evaluation for venous malformation treated with a Japanese herbal medicine.
Japanese herbal medicine for venous malformation.
Japan |
venous malformation
Pediatrics | Radiology | Neurosurgery |
Cardiovascular surgery | Plastic surgery |
Others
NO
The assessment of whether a Chinese Herbal medicine (Keishibukuryo-gan-ka-yokuinin) has an ability to contract of venous malformation volume or not.
Safety,Efficacy
Exploratory
To assess the contraction rate of venous malformation volume as observed using MRI.
(Before administration and at least 3 months after administration to assess treatment response.)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Duration of administration: 8 months
Dose of administration:
(adult)7.5g/kg/day
(under 18year-old)0.4g/kg/day
(maximum dose 7.5g/day)
3 | years-old | <= |
Not applicable |
Male and Female
(1) Patients are diagnosed with venous malformation based on imaging and physical examination.
(2) It is capable of assess the volume by MRI T2-weighted images.(It has reproducible images.)
(3) Age of at least 3 years and older at the time of registration.
(4)Patients have nothing in planned for some active treatment at the start of the study.
(5)All patients provided written informed consent before initiation of study-related procedures.
(1)Patients have drug allergy for an Japanese herbal medicine.
(2)Patients are difficult to continue medication.
(3)Pregnant or lactating women.
(4)Volume assessment is difficult on MRI
(MRI image is poorly-reproducible)
(5)Patients with venous malformation requiring treatment with resection or sclerotherapy as soon as possible.
(6)others(if deems inappropriate by the doctor.)
20
1st name | |
Middle name | |
Last name | Yuko Katayama |
Okayama university hospital
Depertment of plastic surgery
2-5-1, Shikata-cho, Kita-ku Okayama-shi, Okayama, 700-8558, Japan
086-235-7214
u_choppling@yahoo.co.jp
1st name | |
Middle name | |
Last name | Yuko Katayama |
Okayama University Hospital
Plastic Surgery
2-5-1, Shikata-cho, Kita-ku Okayama-shi, Okayama, 700-8558, Japan
086-235-7214
u_choppling@yahoo.co.jp
Department of plastic surgery and radiology, Okayama University Hospital.
Department of plastic surgery and radiology, Okayama University Hospital.
Self funding
NO
2016 | Year | 03 | Month | 16 | Day |
Unpublished
Completed
2016 | Year | 01 | Month | 25 | Day |
2016 | Year | 01 | Month | 25 | Day |
2016 | Year | 03 | Month | 16 | Day |
2019 | Year | 03 | Month | 31 | Day |
2016 | Year | 03 | Month | 02 | Day |
2019 | Year | 03 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024175
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