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 |
The effectiveness and the safety of TJ-41 hochuekkito on improving physical strength in patients after hip fracture
The effectiveness of hochuekkito on the physical strength in hip fracture patients
The effectiveness and the safety of TJ-41 hochuekkito on improving physical strength in patients after hip fracture
The effectiveness of hochuekkito on the physical strength in hip fracture patients
Japan |
Patients undergoing rehabilitation after hipfracture
Orthopedics | Rehabilitation medicine |
Others
NO
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.
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
Physical strength
(Physical activity and motivation)
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
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
NO
NO
Institution is not considered as adjustment factor.
YES
Central registration
2
Treatment
Medicine |
Rehabilitation + TSUMURA Hochuekkito extract granules for ethical use (Hochuekkito grope)
Rehabilitation alone (control group)
65 | years-old | <= |
Not applicable |
Male and Female
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
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
40
1st name | Mitsunobu |
Middle name | |
Last name | Watanabe |
Konan hospital
Department of Rehabilitation
862-0970
5-1-37 Toroku, Chuo-ku, Kumamoto
096-375-1112
konan-hp@kyouninkai.jp
1st name | Mitsunobu |
Middle name | |
Last name | Watanabe |
Konan hospital
Department of Rehabilitation
862-0970
5-1-37 Toroku, Chuo-ku, Kumamoto
096-375-1112
konan-hp@kyouninkai.jp
Konan hospital
Tsumura & CO.
Other
Konan Hospital
5-1-37 Toroku, Chuo-ku, Kumamoto
096-375-1112
konan-hp@kyouninkai.jp
NO
2017 | Year | 05 | Month | 18 | Day |
Unpublished
39
Completed
2017 | Year | 03 | Month | 03 | Day |
2017 | Year | 03 | Month | 04 | Day |
2017 | Year | 05 | Month | 18 | Day |
2020 | Year | 05 | Month | 31 | Day |
2017 | Year | 05 | Month | 04 | Day |
2021 | Year | 05 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031150