Unique ID issued by UMIN | UMIN000032018 |
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Receipt number | R000036539 |
Scientific Title | Treatment with Kamikihito for Anxiety in Frail Patients: A Randomized, Parallel-group Comparison Exploratory Study, Including Exploration of Relationship with Intestinal Flora |
Date of disclosure of the study information | 2018/03/31 |
Last modified on | 2023/09/22 14:36:18 |
Treatment with Kamikihito for Anxiety 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 Kamikihito for Anxiety in Frail Patients
Treatment with Kamikihito for Anxiety 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 Kamikihito for Anxiety in Frail Patients
Japan |
Frailty
Geriatrics |
Others
NO
We investigate the efficacy and safety of kamikihito on anxiety in frail patients.
Efficacy
Exploratory
Pragmatic
Not applicable
Anxiety, Depression: HADS (Hospital Anxiety and Depression Scale) at 24 weeks
At 24 weeks
1. Fatigue
2. Appetite
3. The Kihon Checklist
4. Activity
5. Body composition
6. Physical performance
7. Cognitive function
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 Kamikihito Extract Granules, 7.5g 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 has possessed of the Kihon Checklist No. 21 to 25 for depression > 1 point at baseline
3. Patient who has possessed of HADS-A score > 3 points 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
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
2018 | Year | 03 | Month | 31 | Day |
Unpublished
No longer recruiting
2018 | Year | 03 | Month | 30 | Day |
2018 | Year | 03 | Month | 30 | Day |
2018 | Year | 06 | Month | 01 | 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 |
2018 | Year | 03 | Month | 30 | Day |
2023 | Year | 09 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036539
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