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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044024
Receipt No. R000050269
Scientific Title A study for the effect of Ninjin'yoeito, a Kampo medicine, on the postoperative course of elderly patients with proximal hip fractures
Date of disclosure of the study information 2021/05/01
Last modified on 2021/04/23

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Basic information
Public title A study for the effect of Ninjin'yoeito, a Kampo medicine, on the postoperative course of elderly patients with proximal hip fractures
Acronym A study for the effect of Ninjin'yoeito, a Kampo medicine, on the postoperative course of elderly patients with proximal hip fractures
Scientific Title A study for the effect of Ninjin'yoeito, a Kampo medicine, on the postoperative course of elderly patients with proximal hip fractures
Scientific Title:Acronym A study for the effect of Ninjin'yoeito, a Kampo medicine, on the postoperative course of elderly patients with proximal hip fractures
Region
Japan

Condition
Condition Patients undergoing rehabilitation after proximal hip fracture
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of Ninjin'yoeito on the postoperative course of elderly patients with proximal hip fractures
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Functional Independence Measure (FIM)
Key secondary outcomes 1) Weight loss rate
2) Nutritional indicators (serum albumin level, CONUT, GNRI, MNA-SF, dietary sufficiency rate)
3) Physical index (BMI,IBW)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Ninjin'yoeito is administrated in patients with proximal hip fracture 4 weeks after surgery
Interventions/Control_2 Ninjin'yoeito is not administrated in patients with proximal hip fracture after surgery
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 aged 65 years or older (when giving informed consent)
4) Patients who can take oral administrationof investigational drugs
5) Inpatients
6) 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 Takuji
Middle name MATSUMOTO
Last name Matsumoto
Organization Nokami Kosei General Hospital
Division name Department of Orthopedic Surgery
Zip code 640-1141
Address 198, Shobata, Kinino-cho, Kaiso-gun, Wakayama
TEL 0734892178
Email matsumoto_t@nokami-hospital.jp

Public contact
Name of contact person
1st name TAKUJI
Middle name MATSUMOTO
Last name MATSUMOTO
Organization Nokami Kosei General Hospital
Division name Department of Orthopedic Surgery
Zip code 640-1141
Address 198, Shobata, Kinino-cho, Kaiso-gun, Wakayama
TEL 0734892178
Homepage URL
Email matsumoto_t@nokami-hospital.jp

Sponsor
Institute Nokami Kosei General Hospital
Institute
Department

Funding Source
Organization Kracie
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics Committee of Nokami Kosei General Hospital
Address 198, Shobata, Kinino-cho, Kaiso-gun, Wakayama
Tel 0734892178
Email info@nokami-hospital.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 野上厚生総合病院(和歌山県)

Other administrative information
Date of disclosure of the study information
2021 Year 05 Month 01 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
2020 Year 07 Month 10 Day
Date of IRB
2020 Year 07 Month 10 Day
Anticipated trial start date
2021 Year 05 Month 01 Day
Last follow-up date
2022 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 04 Month 23 Day
Last modified on
2021 Year 04 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050269

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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