Frailty
Conditions
Interventions
TSUMURA Ninjinyoeito Extract Granules, 9g per day, 24 weeks
No treatment
Sponsors
National Center Geriatrics and Gerontology
Nagoya Institute of Technology Kurume University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue: Chalder's fatigue scale at 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactHidenori Arai
National Center Geriatrics and Gerontology Department of Geriatric Medicine
Outcome results
None listed