Effects of Hochuekkito in apathetic patients with chronic obstructive pulmonary disease who receive pulmonary rehabilitation

JRCT ID: jRCTs061180042

Registered date:08/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Chronic obstructive pulmonary disease
• Date of first enrollment: 11/04/2018
• Target sample size: 40
• Study type: Interventional

Intervention(s)

arm A: Hochuekkito is administrated in apathetic patients with chronic obstructive pulmonary disease who receive pulmonary rehabilitation.
arm B: Hochuekkito is not administrated in apathetic patients with chronic obstructive pulmonary disease who receive pulmonary rehabilitation.

Outcome(s)

• Primary Outcome: Apathy scale score, Numbers of steps
• Secondary Outcome: Patient Health Questionnaire (PHQ)-9 score, COPD assessment test score, Modified Medical Research Council dyspnea scale, VAS for dyspnea, VAS for fatigue, Body weight, Body mass index, Rate of acute exacerbation, Completion rate of pulmonary rehabilitation, Compliance of medicine, Laboratory data, Adverse events

Key inclusion & exclusion criteria

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

Include criteria

1)COPD stage 2-3, FEV1/FVC: less than 70%, FEV1 pred: more than 30%, less than 80%
2)Clinically stable COPD
3)Apathy scale score: more than 16
4)Age: 40 years or older
5)Smoking history: more than 10 pack-years
6)Outpatients
7)Male or female
8)Patients who will be able to take food orally
9) Patients who will write informed consent

Exclude criteria

1)Diagnosed of other pulmonary diseases
2)Diagnosis of an acute exacerbation within 4 weeks
3)Received pulmonary transplantation
4)Patient Health Questionnaire (PHQ)-9 score: more than 15
5) Patients who will not be able to walk or perform activities of daily living due to orthopedic or neurological diseases
6)Undergone pulmonary rehabilitation within 24 weeks
7)Had newly received inhaled or systemic corticosteroids within 2 weeks
8)Received herbal medicine for any problem within 4 weeks
9)Engaged in another clinical trial within 4 weeks
10)Have allergy for herbal medicines
11)alpha1 antitrypsin deficiency
12)Had severe diseases such as autoimmune disease, liver disease, renal disease, heart disease, hematologic disease, and metabolic disease
13)Had a malignancy
14)Pregnant and nursing
15)The physician judged the patient as unable to participate in the present study

Related Information

• Primary Sponsor: Hamada Hironobu
• Source(s) of Monetary Support: Pharmaceutical company Tsumura and Co.
• Secondary ID(s): UMIN000029368