Unique ID issued by UMIN | UMIN000035047 |
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Receipt number | R000039958 |
Scientific Title | Clinical investigation of ninjin'yoeito for psychiatric symptoms and physical frailty among patients with mild cognitive impairment and Alzheimer's disease. |
Date of disclosure of the study information | 2018/11/28 |
Last modified on | 2019/12/23 09:07:08 |
Clinical investigation of ninjin'yoeito for psychiatric symptoms and physical frailty among patients with mild cognitive impairment and Alzheimer's disease.
Effect of ninjin'yoeito among patients with mild cognitive impairment and Alzheimer's disease.
Clinical investigation of ninjin'yoeito for psychiatric symptoms and physical frailty among patients with mild cognitive impairment and Alzheimer's disease.
Effect of ninjin'yoeito among patients with mild cognitive impairment and Alzheimer's disease.
Japan |
mild cognitive impairment or Alzheimer's disease
Geriatrics |
Others
NO
We investigate the efficacy of ninjinyoeito on psychiatric symptoms and physical frailty in patients with mild cognitive impairment and early to moderate Alzheiemr's disease.
Efficacy
Confirmatory
Pragmatic
Not applicable
Psychiatric symptoms: the Neuropsychiatric Inventory at 12 weeks
12 weeks
1) Weight (Body mass index)
2) Nutritional status: Mini Nutritional Assessment-short form
3) Appetite: Simplified Nutritional Appetite Questionnaire
4) Physical performance: grip strength, timed Up and Go test
5) Body composition: Bioelectrical impedance analysis
6) Physical activities: International Physical Activity Questionnaire short version
7) Cognitive function: Mini Mental State Examination
8) Vitality: Vitality Index
9) Depressive mood: 15-Geriatric depression scale
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
YES
NO
YES
Central registration
2
Treatment
Medicine |
Kracie Ninjinyoeito Extract Granules, 7.5g per day, 12 weeks
No treatment
65 | years-old | <= |
89 | years-old | >= |
Male and Female
1) Patients who suffer from weakness, exhaustion, and/or anorexia.
2) Patients with apathy.
3) Patients who were diagnosed with mild cognitive impairment or early to moderate Alzheimer's disease based on the criteria of the NIA-AA.
4) Patients who have MMSE score of 11 points or more.
5) Patients who can walk without assistance.
6) Patients who have provided consent for participation by each subject and a family or caregiver.
7) Patients who can receive cooperation from family or caregiver.
1) Patients who have been taken other kampo medicines in the past month.
2) Patients who have MMSE score of 10 points or less.
3) Patients who switched or newly started using anti-dementia medications within 3 months from the start of the survey.
4) Patients who have been taking sweetroot-containing drug and/or glycyrrhizinate-containing drug.
5) Patients who switched or newly started using antipsychotic medications within 3 months from the start of the survey.
6) Patients who have mental disorders caused by cerebrovascular disorders, head injuries, brain tumors, or encephalitis.
7) Patients whom investigators consider to be ineligible.
40
1st name | Takashi |
Middle name | |
Last name | Sakurai |
National Center Geriatrics and Gerontology
Center for Comprehensive Care and Research on Memory Disorders
474-8511
7-430 Morioka-cho, Obu, Aichi, 474-8511, Japan
0562-46-2311
tsakurai@ncgg.go.jp
1st name | Takashi |
Middle name | |
Last name | Sakurai |
National Center Geriatrics and Gerontology
Center for Comprehensive Care and Research on Memory Disorders
474-8511
7-430 Morioka-cho, Obu, Aichi, 474-8511, Japan
0562-46-2311
tsakurai@ncgg.go.jp
National Center Geriatrics and Gerontology
Kracie & CO.
Profit organization
Japan
Research and Medical Division
7-430 Morioka-cho, Obu, Aichi, 474-8511, Japan
0562-46-2311
yaday@ncgg.go.jp
NO
2018 | Year | 11 | Month | 28 | Day |
Unpublished
10
Completed
2017 | Year | 12 | Month | 13 | Day |
2017 | Year | 12 | Month | 13 | Day |
2018 | Year | 04 | Month | 17 | Day |
2018 | Year | 09 | Month | 13 | Day |
2018 | Year | 11 | Month | 28 | Day |
2019 | Year | 12 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039958
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