UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027244 |
|---|---|
| Receipt number | R000031150 |
| Scientific Title | The effectiveness and the safety of TJ-41 hochuekkito on improving physical strength in patients after hip fracture |
| Date of disclosure of the study information | 2017/05/18 |
| Last modified on | 2021/05/20 12:58:12 |
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Basic information
Public title
The effectiveness and the safety of TJ-41 hochuekkito on improving physical strength in patients after hip fracture
Acronym
The effectiveness of hochuekkito on the physical strength in hip fracture patients
Scientific Title
The effectiveness and the safety of TJ-41 hochuekkito on improving physical strength in patients after hip fracture
Scientific Title:Acronym
The effectiveness of hochuekkito on the physical strength in hip fracture patients
Region
| Japan |
Condition
Condition
Patients undergoing rehabilitation after hipfracture
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effect of hochuekkito, a traditional Japanese medicine, on improving the physical strength in patients undergoing rehabilitation after hip fracture. In addition, we will also evaluate the safety of hochuekkito.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Physical strength
(Physical activity and motivation)
Key secondary outcomes
1) Fatigue: 5 step questionnaire
2) Activities of daily living: Functional Independence Measure (FIM)
3) QOL: EQ-5D-5L Japanese version
4) Appetite: daily caloric intake
5) Body weight
6) Nutrition: Prealbumin level
7) Rehabilitation progress
8) Complication incidence rate
9) Length of stay in hospital
10) Home return rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
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
Rehabilitation + TSUMURA Hochuekkito extract granules for ethical use (Hochuekkito grope)
Interventions/Control_2
Rehabilitation alone (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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients after operation for hip fracture (osteosynthesis or femoral head prosthetic replacement
2) Patients who planned or undergoing postoperative rehabilitation
3) Patients who had walking ability more than indoor self-supporting walking before the injury.
4) Patients who do not planned the treatment by low-intensity pulsed ultrasound (LIPUS)
5) Patients with mini mental state examination (MMSE) score of 10 or more
6) Patients aged 65 years or older (when giving informed consent)
7) Patients who can take oral administrationof investigational drugs
8) Inpatients
9) Patients who are able to give written informed consent
Key exclusion criteria
Patients who have any of the following conditions are excluded.
1) Patients with severe mental disorders
2) Patients with severe complications for liver disease, kidney disease, heart disease, blood disease, autoimmune disease or metabolic disease, etc
3) Patients with malignant tumors or rheumatoid arthritis
4) Patients undergoing dialysis
5) Patients who take concomitant medications or investigational drugs within 2 weeks before starting this study
6) Patients who have a history of allergies or side effects in kampo
7) Patients who judged inappropriate for participation by investigators because they have other conditions
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Mitsunobu |
| Middle name | |
| Last name | Watanabe |
Organization
Konan hospital
Division name
Department of Rehabilitation
Zip code
862-0970
Address
5-1-37 Toroku, Chuo-ku, Kumamoto
TEL
096-375-1112
konan-hp@kyouninkai.jp
Public contact
Name of contact person
| 1st name | Mitsunobu |
| Middle name | |
| Last name | Watanabe |
Organization
Konan hospital
Division name
Department of Rehabilitation
Zip code
862-0970
Address
5-1-37 Toroku, Chuo-ku, Kumamoto
TEL
096-375-1112
Homepage URL
konan-hp@kyouninkai.jp
Sponsor or person
Institute
Konan hospital
Institute
Department
Personal name
Funding Source
Organization
Tsumura & CO.
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
Konan Hospital
Address
5-1-37 Toroku, Chuo-ku, Kumamoto
Tel
096-375-1112
konan-hp@kyouninkai.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
| 2017 | Year | 05 | 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
39
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
| 2017 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 04 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 18 | Day |
Last follow-up date
| 2020 | Year | 05 | 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
| 2017 | Year | 05 | Month | 04 | Day |
Last modified on
| 2021 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031150
| Research Plan | |
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| Registered date | File name |
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