Unique ID issued by UMIN | UMIN000012902 |
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Receipt number | R000015076 |
Scientific Title | A double-blind, placebo controlled, randomized trial to evaluate the efficacy of SE in post-stroke rehabilitation patients. |
Date of disclosure of the study information | 2014/01/27 |
Last modified on | 2015/10/15 15:04:13 |
A double-blind, placebo controlled, randomized trial to evaluate the efficacy of SE in post-stroke rehabilitation patients.
A double-blind, placebo controlled, randomized trial to evaluate the efficacy of SE in post-stroke rehabilitation patients.
A double-blind, placebo controlled, randomized trial to evaluate the efficacy of SE in post-stroke rehabilitation patients.
A double-blind, placebo controlled, randomized trial to evaluate the efficacy of SE in post-stroke rehabilitation patients.
Japan |
Stroke
Rehabilitation medicine |
Others
NO
To evaluate the efficacy of SE on the maintenance or hypertrophy of skeketal muscle mass in post-stroke rehabilitation patients.
Efficacy
Exploratory
Pragmatic
Not applicable
Skeletal muscle mass (BIA, thigh muscle area by Computed tomography)
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
NO
Central registration
2
Treatment
Food |
SE(Extract of Citrus species)
Placebo
50 | years-old | <= |
Not applicable |
Male and Female
1. Aged 50 or older
2. Primary disease is first ever stroke
3. Within two weeks after admission
4. SIAS Knee-Extension Test score is within 3
5. Patients who can ride normal wheelchair
1. Impossible to get informed concent by cognitive deficit
2. Impossible to be treated with exercise therapy due to complication or previous disease
3. Impossible to swallow experimental food
4. Patients who receive parenteral or enteral Nutrition
5. peel of citrus species supplementation
6. Patients who are judged inappropriate for the study by the physician
40
1st name | |
Middle name | |
Last name | Kunitsugu Kondo |
Tokyo Bay Rehabilitation Hospital
Tokyo Bay Rehabilitation Hospital
4-1-1 Yatsu, Narashino-shi, Chiba
047-453-9000
k.kondo@wanreha.net
1st name | |
Middle name | |
Last name | Kaoru Honaga |
Tokyo Bay Rehabilitation Hospital
Rehabilitation Department
4-1-1 Yatsu, Narashino-shi, Chiba
047-453-9000
rh_fortune@hotmail.com
Tokyo Bay Rehabilitation Hospital
Morinaga Milk Industry Co, Ltd.
Profit organization
NO
2014 | Year | 01 | Month | 27 | Day |
Unpublished
Completed
2013 | Year | 04 | Month | 22 | Day |
2013 | Year | 11 | Month | 01 | Day |
2016 | Year | 11 | Month | 01 | Day |
2014 | Year | 01 | Month | 20 | Day |
2015 | Year | 10 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015076
Research Plan | |
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Registered date | File name |
2020/12/30 | S1 File Protocol in English and Japanese.pdf |
Research case data specifications | |
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Registered date | File name |
Research case data | |
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Registered date | File name |
2020/12/30 | S3 File-Data set.pdf |