UMIN-CTR Clinical Trial

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
Email	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
Email	K_kishida@inforlive.com

Sponsor
Institute	Nishimura Pediatric Clinic
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052154