UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028737 |
|---|---|
| Receipt number | R000032887 |
| Scientific Title | Study on the preventive effect of Chinese herbal medicine for deep venous thromboembolism |
| Date of disclosure of the study information | 2017/08/18 |
| Last modified on | 2017/08/18 19:42:02 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Study on the preventive effect of Chinese herbal medicine for deep venous thromboembolism
Acronym
Prevention of VTE by Chinese herbal medicine
Scientific Title
Study on the preventive effect of Chinese herbal medicine for deep venous thromboembolism
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Michiro Yanagisawa |
Organization
Hirosaki University Hospital
Division name
Orthopedic surgery
Zip code
Address
53 Hon-cho Hirosaki city, Aomori
TEL
0172-39-5083
yanagi96@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michiro Yanagisawa |
Organization
Hirosaki University Hospital
Division name
Orthopedic surgery
Zip code
Address
53 Hon-cho Hirosaki city, Aomori
TEL
0172-39-5083
Homepage URL
yanagi96@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Preinitiation
Date of protocol fixation
| 2017 | Year | 08 | Month | 18 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032887
