UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015092 |
|---|---|
| Receipt number | R000014717 |
| Scientific Title | A randomized control trial of Hotyuekkito in patients with chronic obstructive pulmonary disease who receive pulmonary rehabilitation |
| Date of disclosure of the study information | 2014/09/08 |
| Last modified on | 2017/10/01 17:43:13 |
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Basic information
Public title
A randomized control trial of Hotyuekkito in patients with chronic obstructive pulmonary disease who receive pulmonary rehabilitation
Acronym
A randomized control trial of Hotyuekkito in patients with chronic obstructive pulmonary disease who receive pulmonary rehabilitation
Scientific Title
A randomized control trial of Hotyuekkito in patients with chronic obstructive pulmonary disease who receive pulmonary rehabilitation
Scientific Title:Acronym
A randomized control trial of Hotyuekkito in 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 Hotyuekkito in 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
Six minutes walking test
Safety
Key secondary outcomes
Grasping powergrip, Body weight, Body mass index, Hematological data, Modified Medical Research Council dyspnea scale, Quality of life questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
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
Hotyuekkito is administrated in patients with chronic obstructive pulmonary disease who receive pulmonary rehabilitation
Interventions/Control_2
Hotyuekkito is not administrated in 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)No reciving pulmonary rehabilitation within 24 weeks
4)Ideal body weight <100%
5)Age: 40 years or older
6)Smoking history > 10 pack-years
7)Male or female
8)Patients who will be able to receive treatment for 12 weeks
9)Written informed consent
Key exclusion criteria
1)Diagnosed other pulmonary diseases
2)No acute exacervation within 4 weeks
3)Receiving pulmonary transplantation
4)Receiving herbal medicine within 4 weeks
5)Receiving inhaled or systemic steroid therapy within 2 weeks
6)Engage other clinical trial within 4 weeks
7)alpha1 antitrypsin deficiency
8)Severe other diseases such as malignancy, autoimmune disease, liver disease, renal disease, heart disease, hematologic disease, and metabolic disease
9)Pregnant and nursing
10)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
hirohamada@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noboru Hattori |
Organization
Hiroshima University Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
1-2-3, Kasumi, Minami-ku, Hiroshim
TEL
082-257-5196
Homepage URL
nhattori@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital
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
Address
Tel
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
| 2014 | Year | 09 | Month | 08 | 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
Completed
Date of protocol fixation
| 2013 | Year | 10 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 08 | 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
| 2014 | Year | 09 | Month | 08 | Day |
Last modified on
| 2017 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014717
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
