anxiety in frail with depression symptom
Conditions
Interventions
TSUMURA Kamikihito Extract Granules, 7.5g per day, 24 weeks
Sponsors
Arai Hidenori
Tsumura & CO.
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 |
|---|---|
| 24 weeks 1. Fatigue: Chalder's fatigue scale 2. Appetite: SNAQ-JE, Simplified Nutritional Appetite Questionnaire for the Japanese elderly 3. The Kihon Checklist 4. Activity: Actigraph 5. Body composition: body weight, lean body mass/fat mass 6. Physical performance: SPPB, Short Physical Performance Battery; handgrip strength 7. Cognitive function: MMSE, MINI-Mental State Examination; NCGG-FAT, National Center for Geriatrics and Gerontology-Functional Assessment Tool | — |
Contacts
Public ContactHidenori Arai
National Center for Geriatrics and Gerontology
Outcome results
None listed