NINJA-COP study.

JRCT ID: jRCTs051240076

Registered date:27/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: chronic obstructive pulmonary disease (COPD)
• Date of first enrollment: 16/10/2024
• Target sample size: 50
• Study type: Interventional
• Intervention(s): 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 for 24 weeks.

Outcome(s)

• Primary Outcome: Percent change in body weight from start of study to 24 weeks

Secondary Outcome

>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

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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 or Enteral nutrient formulations within 1 month from the time of obtaining consent
6) Patients who are participating in another clinical trial or have participated in other clinical trials within 1 month from the time of obtaining consent
7) Patients with a history of pseudoaldosteronism, myopathy, liver dysfunction, or jaundice caused by Kampo medicines
8) Patients with pacemakers
9) Patients who was judged to be inadequate according to the judgment of the examination medical attendant

Related Information

• Primary Sponsor: Yamamoto Yoshifumi
• Source(s) of Monetary Support: Kracie, Ltd