venous malformation
Conditions
Interventions
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)
Sponsors
Department of plastic surgery and radiology, Okayama University Hospital.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (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.
Exclusion criteria
Exclusion criteria: (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.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.) | — |
Countries
Japan
Contacts
Public ContactYuko Katayama
Okayama University Hospital Plastic Surgery
Outcome results
None listed