Frailty
Conditions
Interventions
TSUMURA Kamikihito Extract Granules, 7.5g 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 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
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 |
|---|---|
| Anxiety, Depression: HADS (Hospital Anxiety and Depression Scale) at 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| At 24 weeks 1. Fatigue 2. Appetite 3. The Kihon Checklist 4. Activity 5. Body composition 6. Physical performance 7. Cognitive function | — |
Countries
Japan
Contacts
Public ContactHidenori Arai
National Center Geriatrics and Gerontology Department of Geriatric Medicine
Outcome results
None listed