Treatment with Ninjinyoeito for Fatigue in Frail Patients: A Randomized, Parallel-group Comparison Exploratory Study, Including Exploration of Relationship with Intestinal Flora
Not Applicable
- Conditions
- Frailty
- Registration Number
- JPRN-UMIN000029976
- Lead Sponsor
- ational Center Geriatrics and Gerontology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fatigue: Chalder's fatigue scale at 24 weeks
- Secondary Outcome Measures
Name Time Method 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