chronic obstructive pulmonary disease (COPD) chronic obstructive pulmonary disease (COPD)
Conditions
Interventions
The active drug group will take 7.5 g of Ninjin'yoeito, and the placebo group will take 7.5 g of the placebo drug (containing 4.5% Ninjin'yoeito) twice a day in divided doses before or between meals f
Sponsors
Yamamoto Yoshifumi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) COPD patients visiting the study facility who received standard therapy for at least 1 month by the time consent is obtained 2) Patients with %IBW under 90% or BMI under 20 kg/m2 or Alb under 3.5 g/dL (institutional criteria) 3) Patients with anorexia and SNAQ score of 14 or less 4) Patients over 40 years old 5) Patients who provided written consent for their participation in the study
Exclusion criteria
Exclusion criteria: 1) Patients who cannot properly perform respiratory function tests 2) Patients with chronic respiratory tract infections such as nontuberculous mycobacteriosis 3) Patients with active malignant tumor 4) Patients diagnosed with depression, schizophrenia, etc, and receiving medication 5) Patients who have been taking Kampo medicines within 1 month from the time of obtaining consent 6) Patients who started taking Enteral nutrient formulations within 3 months from the time of obtaining consent 7) Patients who are participating in another clinical trial or have participated in other clinical trials within 1 month from the time of obtaining consent 8) Patients with a history of pseudoaldosteronism, myopathy, liver dysfunction, or jaundice caused by Kampo medicines 9) Patients with pacemakers 10) Patients who was judged to be inadequate according to the judgment of the examination medical attendant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in body weight from start of study to 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| >Changes in nutritional status indicators BMI Appetite (SNAQ) mini nutritional assessment-short form (MNA-SF) Blood biochemical tests: albumin, pre-albumin, total protein, Hb, Fe, ferritin Body composition (bioelectrical impedance (BIA) method): LBM, FM >Changes in evaluation indices of overall COPD pathology COPD exacerbation frequency COPD Assessment Test (CAT) modified British Medical Research Council (mMRC) hospital anxiety and depression scale (HADS) Respiratory function tests: FEV1, %FEV1, VC, FVC, %FVC >Changes in ADL indicators Fatigue (VAS) Grip strength Life space assessment (LSA) >Changes in systemic inflammatory indices in COPD Blood biochemical tests: CRP, IL-6, TNF-alpha | — |
Contacts
Public ContactYoshifumi Yamamoto
Nara Medical University Hospital
Outcome results
None listed