UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038213 |
|---|---|
| Receipt number | R000043553 |
| Scientific Title | Effects of Juzentaihoto on total hip arthroplasty: randomized controlled trial |
| Date of disclosure of the study information | 2019/10/07 |
| Last modified on | 2020/10/07 08:45:31 |
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Basic information
Public title
Effect of Juzentaihoto on total hip arthroplasty: randomized controlled trial
Acronym
Effects of Juzentaihoto on total hip arthroplasty
Scientific Title
Effects of Juzentaihoto on total hip arthroplasty: randomized controlled trial
Scientific Title:Acronym
Effects of Juzentaihoto on total hip arthroplasty
Region
| Japan |
Condition
Condition
total hip arthroplasty
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Juzen-taiho-to is used in Kampo medicine for blood and emptiness, and has been used for the purpose of increasing physical strength after surgery and postoperatively. Immunostimulatory effects have been shown in animal experiments postoperative immunostimulatory action, anemia improvement, and nutritional improvement in gastrointestinal cancer and breast cancer have been reported. In addition, the improvement of nutritional status after surgery for gastric cancer patients and the reduction of NK activity can be expected to suppress the surgical invasion and promote early recovery of physical fitness. However, studies showing the effect on musculoskeletal surgery were not within the reach of us. This study is to investigate the effect of Juzentaihoto on musculoskeletal surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Alb change rate 4 weeks before surgery and 1, 3, 5, 7, 14 days after surgery
Key secondary outcomes
Hb value, infection rate, ADL improvement rate, length of hospital stay, home discharge rate, CRP value, NRS, JOA score, walking ability
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of Juzentaihoto
Interventions/Control_2
Non-administration of Juzentaihoto
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who receive unilateral THA at this hospital
Key exclusion criteria
Patients allergic to Juzentaihoto
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Takashima |
Organization
Showa University Fujigaoka Hospital
Division name
Orthopedics
Zip code
2278501
Address
1-30 Fujigaoka, Aoba-ku, Yokohama, Kanagawa
TEL
0459711151
takashimamasashi@hotmail.co.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Takashima |
Organization
Showa University Fujigaoka Hospital
Division name
Orthopedics
Zip code
2278501
Address
1-30 Fujigaoka, Aoba-ku, Yokohama, Kanagawa
TEL
0459711151
Homepage URL
takashimamasashi@hotmail.co.jp
Sponsor or person
Institute
Showa University
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
Showa University Fujigaoka Hospital Clinical Trial Review Committee
Address
1-30 Fujigaoka, Aoba-ku, Yokohama, Kanagawa
Tel
0459711151
f-irb@cmed.showa-u.ac.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
| 2019 | Year | 10 | Month | 07 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 10 | Month | 06 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 09 | Month | 11 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 06 | Day |
Last modified on
| 2020 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043553
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
