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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033212
Receipt No. R000037871
Scientific Title Effect of propolis among frailty comorbid COPD patients.
Date of disclosure of the study information 2018/07/02
Last modified on 2018/06/30

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Basic information
Public title Effect of propolis among frailty comorbid COPD patients.
Acronym Effect of propolis among frailty comorbid COPD patients.
Scientific Title Effect of propolis among frailty comorbid COPD patients.
Scientific Title:Acronym Effect of propolis among frailty comorbid COPD patients.
Region
Japan

Condition
Condition COPD
Classification by specialty
Medicine in general Pneumology Geriatrics
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the effect of propolis among frailty comorbid COPD patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Difference of frailty index before and after intake of propolis.
Key secondary outcomes Socres of QOL,CAT,HADS,mMRC, and spirometry

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Propolis 101.7mg X3 per day, everyday, for 3 month.
Interventions/Control_2 Placebo 101.7mg X3 per day, everyday, for 3 month.
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
20 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria COPD patients with frailty or pre-frailty.
Key exclusion criteria Patients with respiratory disease other than COPD.Patients with malignant tumor.
Not able to assess the primary or secondary outcomes.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuya Homma
Organization Showa University School of Medicine
Division name Department of Medicine, Division of Allergology and Respiratory Medicine
Zip code
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL 03-3784-8000
Email oldham726@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuya Homma
Organization Showa University School of Medicine
Division name Department of Medicine, Division of Allergology and Respiratory Medicine
Zip code
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL 03-3784-8000
Homepage URL
Email oldham726@yahoo.co.jp

Sponsor
Institute Showa University School of Medicine, Department of Medicine, Division of Allergology and Respiratory Medicine
Institute
Department

Funding Source
Organization Showa University School of Medicine, Department of Medicine, Division of Allergology and Respiratory Medicine
Organization
Division
Category of Funding Organization Self funding
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
2018 Year 07 Month 02 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 Enrolling by invitation
Date of protocol fixation
2018 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 07 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
2018 Year 06 Month 30 Day
Last modified on
2018 Year 06 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037871

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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