Unique ID issued by UMIN | UMIN000029976 |
---|---|
Receipt number | R000034238 |
Scientific Title | Treatment with Ninjinyoeito for Fatigue in Frail Patients: A Randomized, Parallel-group Comparison Exploratory Study, Including Exploration of Relationship with Intestinal Flora |
Date of disclosure of the study information | 2017/11/20 |
Last modified on | 2023/09/22 14:35:01 |
Treatment with Ninjinyoeito for Fatigue in Frail Patients: A Randomized, Parallel-group Comparison Exploratory Study, Including Exploration of Relationship with Intestinal Flora
A Randomized, Parallel-group Comparison Exploratory Study of Ninjinyoeito for Fatigue in Frail Patients (eF3 Study)
Treatment with Ninjinyoeito for Fatigue in Frail Patients: A Randomized, Parallel-group Comparison Exploratory Study, Including Exploration of Relationship with Intestinal Flora
A Randomized, Parallel-group Comparison Exploratory Study of Ninjinyoeito for Fatigue in Frail Patients (eF3 Study)
Japan |
Frailty
Geriatrics |
Others
NO
We investigate the efficacy and safety of ninjinyoeito on fatigue in cognitive frail patients.
Efficacy
Confirmatory
Pragmatic
Not applicable
Fatigue: Chalder's fatigue scale at 24 weeks
24 weeks
1.Appetite: SNAQ-JE, Simplified Nutritional Appetite Questionnaire for the Japanese elderly
2.The Kihon Checklist
3.Activity: Actigraph
4.Body composition: body weight, lean body mass/fat mass
5. Physical performance: SPPB, Short Physical Performance Battery, handgrip strength
6. Cognitive function:MINI-Mental State Examination, National Center for Geriatrics and Gerontology-Functional Assessment Tool
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
YES
NO
Institution is considered as a block.
YES
Central registration
2
Treatment
Medicine |
TSUMURA Ninjinyoeito Extract Granules, 9g per day, 24 weeks
No treatment
65 | years-old | <= |
Not applicable |
Male and Female
1. Frail or pre-frail patient: the Kihon Checklist > 3 points
2. Patient who answered yes on the Kihon Checklist No. 25 for fatigue at baseline
3. Patient who has possessed of MMSE score > 23 points, and >0 points on the sum of Kihon Checklist No. 18-20 for cognitive dysfunction at baseline
1. Patient who has had surgical resection of gastrointestinal tract or under the treatment for gastrointestinal disturbance
2. Dementia, major depression or bipolar disorder within the previous year, and alcoholism, drug addiction, within the previous 2 years
3. Patients who has life-threatening diseases such as malignant tumor
50
1st name | Hidenori |
Middle name | |
Last name | Arai |
National Center Geriatrics and Gerontology
President Office
474-0038
7-430 Morioka-cho, Obu, Aichi, 474-8511, Japan
0562-46-2311
harai@ncgg.go.jp
1st name | Hidenori |
Middle name | |
Last name | Arai |
National Center Geriatrics and Gerontology
Department of Geriatric Medicine
474-0038
7-430 Morioka-cho, Obu, Aichi, 474-8511, Japan
0562-46-2311
harai@ncgg.go.jp
National Center Geriatrics and Gerontology
Tsumura & CO.
Profit organization
Japan
Nagoya Institute of Technology
Kurume University
Fujita Health University
1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi
0562-93-2865
kenshien@fujita-hu.ac.jp
NO
国立長寿医療研究センター
2017 | Year | 11 | Month | 20 | Day |
Unpublished
No longer recruiting
2017 | Year | 09 | Month | 13 | Day |
2017 | Year | 10 | Month | 03 | Day |
2017 | Year | 11 | Month | 20 | Day |
2022 | Year | 03 | Month | 31 | Day |
2022 | Year | 12 | Month | 31 | Day |
2022 | Year | 12 | Month | 31 | Day |
2023 | Year | 06 | Month | 30 | Day |
2017 | Year | 11 | Month | 15 | Day |
2023 | Year | 09 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034238
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |