chronic obstructive pulmonary disease, frailty
Conditions
Interventions
arm A: Ninjinyoeito extract fine granules are divided into two doses of 7.5 g daily and orally administered before or between meals for 24 weeks. The dose may be reduced to 3.75 g daily for 12 weeks (
Sponsors
Sagara Hironori
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) COPD patients who are visiting the study facility and have received standard therapy for at least 1 month by the time consent is obtained 2) Patient with prefrailty (1 or 2 out of 5 items) or frailty (3 or more items out of 5 items) with any of weight loss, muscle weakness, tiredness, decreased walking speed, and decreased physical activity based on the revised J-CHS criteria 3) Patients who have given their informed consent to participate in this study 4) Patients with a smoking history of 10 pack years or with same level of air pollution exposure 5) Patients with physical weakness, fatigue, loss of appetite, rash, cold limbs, and anemia
Exclusion criteria
Exclusion criteria: 1) Patients who cannot properly perform respiratory function tests 2) Patients with clinical respiratory diseases other than COPD (excluding asthma) 3) Patients with any acute disease within 3 months of study registration 4) Patients with a clear decline in cognitive function 5) When walking is extremely difficult due to neurological factors 6) Patients who have been taking Kampo medicines within 1 month from the time of obtaining consent 7) Patients with active malignant tumor 8) Patients who have participated in other clinical trials within the past 1 month 9) Patients who was judged to be inadequate according to the judgment of the examination medical attendant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Grip strength | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Simplified Nutritional Appetite Questionnaire (SNAQ) 2) COPD Assessment Test (CAT) 3) modified Medical Research Council (mMRC) 4) Hospital Anxiety and Depression Scale (HADS) 5) Bioelectrical impedance analysis (BIA) 6) J-CHS criteria (body weight,(grip strength), fatigue, walking speed, physical activity) 7) Respiratory function test 8) Hematological test 9) Blood biochemical test | — |
Contacts
Public ContactAkihiko Tanaka
Showa Medical University Hospital
Outcome results
None listed