UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029368 |
|---|---|
| Receipt number | R000033562 |
| Scientific Title | A randomized control trial of Hochuekkito in apathetic patients with chronic obstructive pulmonary disease who receive pulmonary rehabilitation |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2022/02/14 18:11:46 |
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Basic information
Public title
A randomized control trial of Hochuekkito in apathetic patients with chronic obstructive pulmonary disease who receive pulmonary rehabilitation
Acronym
A randomized control trial of Hochuekkito in apathetic patients with chronic obstructive pulmonary disease who receive pulmonary rehabilitation
Scientific Title
A randomized control trial of Hochuekkito in apathetic patients with chronic obstructive pulmonary disease who receive pulmonary rehabilitation
Scientific Title:Acronym
A randomized control trial of Hochuekkito in apathetic patients with chronic obstructive pulmonary disease who receive pulmonary rehabilitation
Region
| Japan |
Condition
Condition
chronic obstructive pulmonary disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the efficacy and safety of Hochuekkito in apathetic patients with chronic obstructive pulmonary disease who receive pulmonary rehabilitation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Apathy scale score, Numbers of steps, 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, Hematological data, Adverse events
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Other |
Interventions/Control_1
Hochuekkito is administrated in apathetic patients with chronic obstructive pulmonary disease who receive pulmonary rehabilitation
Interventions/Control_2
Hochuekkito is not administrated in apathetic patients with chronic obstructive pulmonary disease who receive pulmonary rehabilitation
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)COPD stage 2-3, FEV1/FVC<70%, 30%<FEV1 pred<70%
2)Clinically stable COPD
3)Apathy scale score > 16
4)Age: 40 years or older
5)Smoking history > 10 pack-years
6)Patients who will be able to receive treatment for 12 weeks
7)Male or female
8)Patients who will be able to take food orally
9) Patients who will write informed consent
Key exclusion criteria
1)Diagnosed other pulmonary diseases
2)No acute exacerbation within 4 weeks
3)Receiving pulmonary transplantation
4)PHQ-9 score > 15
5) Patients who will not able to walk or perform activities of daily living due to bone and joint diseases or neurological disorders
6)No reciving pulmonary rehabilitation within 24 weeks
7)Receiving inhaled or systemic steroid therapy within 2 weeks
8)Receiving herbal medicine within 4 weeks
9)Engage other clinical trial within 4 weeks
10)Patients who have allergy for herbal medicines
11)alpha1 antitrypsin deficiency
12)Severe other diseases such as malignancy, autoimmune disease, liver disease, renal disease, heart disease, hematologic disease, and metabolic disease
13)Pregnant and nursing
14)Inappropriate patients
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hironobu |
| Middle name | |
| Last name | Hamada |
Organization
Hiroshima University
Division name
Department of Physical Analysis and Therapeutic Sciences
Zip code
834-8551
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
082-257-5420
hirohamada@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Iwamoto |
Organization
Hiroshima University Hospital
Division name
Department of Respiratory Medicine
Zip code
734-8551
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
082-257-5196
Homepage URL
hir@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Tsumura
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima University Certified Review Board
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
Tel
082-257-1551
iryo-seisaku@office.hiroshima-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
https://jrct.niph.go.jp/latest-detail/jRCTs061180042
Publication of results
Unpublished
Result
URL related to results and publications
https://jrct.niph.go.jp/latest-detail/jRCTs061180042
Number of participants that the trial has enrolled
23
Results
Primary Outcome
Apathy scale scores in Group A were significantly decreased after 4 and 12 weeks of treatment, but no significant change was observed in Group B.
The ratios to baseline in numbers of steps in Group A were significantly higher than those in Group B after 4 and 12 weeks of treatment.
Secondary Outcome
VAS score for dyspnea and CAT score of energy were significantly decreased after 12 weeks of treatment in Group A.
Results date posted
| 2022 | Year | 02 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Group A
Mean age 72.5 years old,
10 males and 1 female,
6 at stage II and 5 at stage III.
Group B
Mean age 76.4 years old,
11 males and 1 female,
6 at stage II and 6 at stage III.
Participant flow
Between April in 2018 and March in 2020, a total 29 apathetic patients with COPD were randomized. Six patients were excluded from the analysis because of withdrawal, disaster, and adverse event. Finally, 23 patients (11 in Group A and 12 in Group B) were enrolled.
Adverse events
One patient in Group A was diagnosed as lumbar spinal stenosis and dropped out from the study. The causal relationship between the therapy and occurrence of lumbar spinal stenosis was not found.
Outcome measures
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
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 01 | Day |
Last modified on
| 2022 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033562
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