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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027244
Receipt No. 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 2019/05/15

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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
Middle name
Last name Mitsunobu Watanabe
Organization Konanhospital
Division name Department of Rehabilitation
Zip code
Address 5--37 Toroku, Chuo-ku, Kumamoto
TEL 096-375-1112
Email konan-hp@kyouninkai.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mitsunobu Watanabe
Organization Konan hospital
Division name Department of Rehabilitation
Zip code
Address 5--37 Toroku, Chuo-ku, Kumamoto
TEL 096-375-1112
Homepage URL
Email konan-hp@kyouninkai.jp

Sponsor
Institute Konan hospital
Institute
Department

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
Address
Tel
Email

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
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
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
2019 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031150

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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