UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051170 |
|---|---|
| Receipt number | R000058306 |
| Scientific Title | Effect of Jidabokuippo on Finger Swelling in Patients Undergoing Upper Extremity Trauma Surgery: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2023/05/26 |
| Last modified on | 2023/05/26 07:55:56 |
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Basic information
Public title
Effect of Jidabokuippo on Finger Swelling in Patients Undergoing Upper Extremity Trauma Surgery: A Randomized Controlled Trial
Acronym
Research for Effect of Jidabokuippo on Finger Swelling
Scientific Title
Effect of Jidabokuippo on Finger Swelling in Patients Undergoing Upper Extremity Trauma Surgery: A Randomized Controlled Trial
Scientific Title:Acronym
Research for Effect of Jidabokuippo on Finger Swelling
Region
| Japan |
Condition
Condition
Upper Extremity Trauma
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of Jidabokuippo on Finger Swelling in Patients Undergoing Upper Extremity Trauma Surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in the size on the affected finger before surgery - day after surgery - 1 week after surgery - 2 weeks after surgery
Key secondary outcomes
Change in the size ratio of the affected/healthy finger before surgery - day after surgery - 1 week after surgery - 2 weeks after surgery
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Treatment group (Tsumura Jidabokuippo 2.5g/package, 1 packet 3 times a day before each meal, for 14 days after surgery)
Interventions/Control_2
Control group
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients undergoing upper extremity trauma surgery in our hospital
2) 18 years older
3) Written consent must be obtained from the subject
Key exclusion criteria
1) Finger trauma
2) Bilateral upper extremity trauma
3) Multiple surgeries for the same trauma
4) Patients deemed clinically unfit by the investigator
Target sample size
82
Research contact person
Name of lead principal investigator
| 1st name | Tomoki |
| Middle name | |
| Last name | KOIDE |
Organization
National Hospital Organization Mito Medical Cente
Division name
Department of Orthopaedic Surgery
Zip code
311-3193
Address
Sakuranosato 280, Ibaraki City, IBARAKI
TEL
029-240-7711
koide.tomoki.mp@alumni.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | OGAWA |
Organization
National Hospital Organization Mito Medical Center
Division name
Department of Orthopaedic Surgery
Zip code
311-3193
Address
Sakuranosato 280, Ibaraki City, IBARAKI
TEL
029-240-7711
Homepage URL
ogawat@tsukuba-seikei.jp
Sponsor or person
Institute
National Hospital Organization Mito Medical Center, Department of Clinical Laboratory
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization, Clinical Research Center
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
National Hospital Organization Mito Medical Center Ethics Review Committee
Address
Sakuranosato 280, Ibaraki City, IBARAKI
Tel
029-240-7711
200-mitokenkyukanri@mail.hosp.go.jp
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
| 2023 | Year | 05 | Month | 26 | 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
| 2023 | Year | 05 | Month | 17 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 24 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 05 | Month | 26 | Day |
Last modified on
| 2023 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058306
