UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047374 |
|---|---|
| Receipt number | R000052154 |
| Scientific Title | A study to verify the antitussive effect of honey |
| Date of disclosure of the study information | 2022/04/03 |
| Last modified on | 2022/05/30 09:48:19 |
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Basic information
Public title
A study to verify the antitussive effect of honey
Acronym
A study to verify the antitussive effect of honey
Scientific Title
A study to verify the antitussive effect of honey
Scientific Title:Acronym
A study to verify the antitussive effect of honey
Region
| Japan |
Condition
Condition
Common cold
Classification by specialty
| Pneumology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of honey to acute cough due to common cold.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Severity of cough on the day after administration and on the second day.
Key secondary outcomes
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
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Acacia honey 3g, 2 days
Interventions/Control_2
Honey flavored syrup, 2 days
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
| 1 | years-old | <= |
Age-upper limit
| 5 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Pediatric patients with cough due to upper respiratory tract infection.
Key exclusion criteria
Children with underlying diseases
Children who are already receiving medication
Children who are judged to need antimicrobial administration
Children with obvious dyspnea or wheezing at the time of visit
Children who have been diagnosed with bronchial asthma in the past
Children who have been diagnosed with pseudocroup
Children whose guardians wish to receive antitussives
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Tatsuo |
| Middle name | |
| Last name | Nishimura |
Organization
Nishimura Pediatric Clinic
Division name
Pediatrics
Zip code
5820021
Address
3-9-3, Kokubu Hommachi, Kashiwara City, Osaka, 582-0021, Japan
TEL
0729786597
tatsuo172460@dc4.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Kazue |
| Middle name | |
| Last name | Kishida |
Organization
Kitaba
Division name
Pharmacy
Zip code
5820021
Address
3-7-8 Kokubuhonmachi, Kashiwara City, Osaka, Japan
TEL
09050634077
Homepage URL
K_kishida@inforlive.com
Sponsor or person
Institute
Nishimura Pediatric Clinic
Institute
Department
Personal name
Funding Source
Organization
Nishimura Pediatric Clinic
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
The Soociety of Ambulatory and General Pediatrics of Japan
Address
Shinjuku Lambdax Building, 4-12, Okubo 2-chome, Shinjuku-ku, Tokyo 169-0072, Japan
Tel
03-5291-6231
gairai-shounika@shunkosha.com
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
| 2022 | Year | 04 | Month | 03 | 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
| 2021 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 06 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 04 | Month | 03 | Day |
Date trial data considered complete
| 2022 | Year | 04 | Month | 03 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 04 | Month | 02 | Day |
Last modified on
| 2022 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052154
| 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 |
