RCT of Ninjin'yoeito in COPD with fatigue

JRCT ID: jRCTs031210583

Registered date:26/01/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Chronic Obstructive Pulmonary Disease (COPD)
• Date of first enrollment: 26/01/2022
• Target sample size: 60
• Study type: Interventional

Intervention(s)

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 (12 weeks).
The study drug, Ninjin'yoeito extract fine granules, should be divided into 7.5 g twice daily and taken orally before or between meals.

Outcome(s)

• Primary Outcome: Fatigue (VAS), walking speed, knee extension leg strength

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Ohbayashi Hiroyuki
• Source(s) of Monetary Support: Kracie Pharma, Ltd.