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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029368
Receipt No. 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 2018/04/01

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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
Middle name
Last name Hironobu Hamada
Organization Hiroshima University
Division name Department of Physical Analysis and Therapeutic Sciences
Zip code
Address 1-2-3, Kasumi, Minami-ku, Hiroshima
TEL 082-257-5420
Email hirohamada@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Iwamoto
Organization Hiroshima University Hospital
Division name Department of Respiratory Medicine
Zip code
Address 1-2-3, Kasumi, Minami-ku, Hiroshima
TEL 082-257-5196
Homepage URL
Email hir@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University
Institute
Department

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
Address
Tel
Email

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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2017 Year 08 Month 07 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 01 Day
Last follow-up date
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
2018 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033562

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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