UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on the preventive effect of Chinese herbal medicine for deep venous thromboembolism
Title of the study (Brief title)	Prevention of VTE by Chinese herbal medicine
Region	Japan

Condition
Condition	Deep venous thromboembolism
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to prove that Chinese herbal medicine is effective for prevention of VTE development after orthopedic surgery
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Presence or absence of deep venous thrombosis at one week after surgery
Key secondary outcomes	D-dimer value Circumference diameter of the thigh and lower leg

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Chinese herbal medicine(keisibukuryougan)
Interventions/Control_2	Low molecular weight heparin
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	50 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Patient who undergo total knee arthroplasty Patient who undergo lumbal surgery Patient who undergo the suegery for proximal femoral fracture
Key exclusion criteria	Patients taking anticoagulants
Target sample size	50

Research contact person
Name of lead principal investigator	Michiro Yanagisawa
Organization	Hirosaki University Hospital
Division name	Orthopedic surgery
Address	53 Hon-cho Hirosaki city, Aomori
TEL	0172-39-5083
Email	yanagi96@hirosaki-u.ac.jp

Public contact
Name of contact person	Michiro Yanagisawa
Organization	Hirosaki University Hospital
Division name	Orthopedic surgery
Address	53 Hon-cho Hirosaki city, Aomori
TEL	0172-39-5083
Homepage URL
Email	yanagi96@hirosaki-u.ac.jp

Sponsor
Institute	Hirosaki University Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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	2017 Year 08 Month 18 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 08 Month 18 Day
Anticipated trial start date	2017 Year 09 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 08 Month 18 Day
Last modified on	2017 Year 08 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032887