Chronic Obstructive Pulmonary Disease (COPD) Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Interventions
Group A: Term1 (12 weeks) is not administered with the study drug, and Term2 (12 weeks) is administered with the study drug.
Group B: Administer the study drug during both Term 1 (12 weeks) and Term 2
Sponsors
Ohbayashi Hiroyuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) COPD patients with stage II or higher who are visiting the research facility 2) Patients who have continued standard treatment for 4 weeks or more by the time consent is obtained 3) Patients with stable respiratory symptoms 4) Patients with fatigue 5) Patients who have written consent to participate in this study 6) Age: 20 years or older
Exclusion criteria
Exclusion criteria: 1) Patients diagnosed with respiratory diseases other than COPD such as asthma (excluding ACO) 2) Patients who newly started pulmonary rehabilitation within 3 months before the start of this study (excluding physical therapy) 3) Patients who have newly started respiratory rehabilitation since the start of this study (excluding physical therapy) 4) Patients who changed the content and frequency of respiratory rehabilitation during this study 5) Patients suffering from acute exacerbations and acute diseases within 4 weeks prior to the start of this study 6) Patients with significant locomotor system / central nervous system disease / neuromuscular disease that affect walking ability 7) Patients with significant neuromuscular disorders due to central nervous system diseases such as cerebral infarction 8) Patients who took Kampo medicine within 4 weeks before the start of this study 9) Patients who have been treated for malignant tumors within 5 years before the start of this study or are currently being treated 10) Patients with serious comorbidities (liver disease, renal disease, heart disease / blood disease, etc.) 11) Patients who have experienced drug allergies due to Kampo medicines in the past 12) Patients with dementia who cannot answer the questionnaire 13) Patients with significantly poor drug adherence 14) Pregnant / lactating women and patients undergoing fertility treatment 15) Patients who was judged to be inadequate according to the judgment of the examination medical attendant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue (VAS), walking speed, knee extension leg strength | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Lower leg circumference 2) Femoral circumference 3) 6-minute walking distance 4) Dual energy X-ray Absorptiometry (DXA):skeletal muscle mass/ skeletal muscle mass index(SMI)/ body fat/ Lean body mass/ bone density 5) Grip strength 6) Finger pinch strength 7) Apathy(VAS) 8) Hospital Anxiety and Depression Scale (HADS) 9) Body weight, Body mass index(BMI) 10) Simplified Nutritional Appetite Question naire (SNAQ) 11) COPD Assessment Test (CAT) 12) modified Medical Research Council (mMRC) 13) Respiratory function test | — |
Contacts
Public ContactHiroyuki Ohbayashi
Tohno Chuo Clinic
Outcome results
None listed