A Randomized, Parallel-group Comparison Exploratory Study of Ninjinyoeito for Fatigue in Frail Patients

JRCT ID: jRCTs041180058

Registered date:28/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: fatigue in frail
• Date of first enrollment: 28/02/2019
• Target sample size: 50
• Study type: Interventional
• Intervention(s): TSUMURA Ninjinyoeito Extract Granules, 9g per day, 24 weeks

Outcome(s)

• Primary Outcome: Fatigue: Chalder's fatigue scale at 24 weeks
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both
• Include 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. Patients who can continue to implement prescribed exercise therapy and nutritional guidance
• Exclude 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

Related Information

• Primary Sponsor: Arai Hidenori
• Secondary Sponsor: Tsumura & CO.
• Secondary ID(s): UMIN000029976