UMIN-CTR Clinical Trial

Basic information
Public title	Volumetric evaluation for venous malformation treated with a Japanese herbal medicine.
Acronym	Japanese herbal medicine for venous malformation.
Scientific Title	Volumetric evaluation for venous malformation treated with a Japanese herbal medicine.
Scientific Title:Acronym	Japanese herbal medicine for venous malformation.
Region	Japan

Condition
Condition	venous malformation
Classification by specialty	Pediatrics Radiology Neurosurgery Cardiovascular surgery Plastic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The assessment of whether a Chinese Herbal medicine (Keishibukuryo-gan-ka-yokuinin) has an ability to contract of venous malformation volume or not.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	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.)
Key secondary outcomes

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	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)
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	3 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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.
Key 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.)
Target sample size	20

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Yuko Katayama
Organization	Okayama university hospital
Division name	Depertment of plastic surgery
Zip code
Address	2-5-1, Shikata-cho, Kita-ku Okayama-shi, Okayama, 700-8558, Japan
TEL	086-235-7214
Email	u_choppling@yahoo.co.jp

Public contact
1st name of contact person	1st name Middle name Last name Yuko Katayama
Organization	Okayama University Hospital
Division name	Plastic Surgery
Zip code
Address	2-5-1, Shikata-cho, Kita-ku Okayama-shi, Okayama, 700-8558, Japan
TEL	086-235-7214
Homepage URL
Email	u_choppling@yahoo.co.jp

Sponsor
Institute	Department of plastic surgery and radiology, Okayama University Hospital.
Institute
Department

Funding Source
Organization	Department of plastic surgery and radiology, Okayama University Hospital.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 16 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	2016 Year 01 Month 25 Day
Date of IRB	2016 Year 01 Month 25 Day
Anticipated trial start date	2016 Year 03 Month 16 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 03 Month 02 Day
Last modified on	2019 Year 03 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024175