UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015092
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email nhattori@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University Hospital
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014717

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.