UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033212 |
|---|---|
| Receipt number | 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 15:08:05 |
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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
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
oldham726@yahoo.co.jp
Sponsor or person
Institute
Showa University School of Medicine, Department of Medicine, Division of Allergology and Respiratory Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037871
