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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000020651
Receipt No. R000023827
Scientific Title Effectiveness of honey and expectorant for nocturnal cough in children with acute upper respiratory infection : a prospective interventional study
Date of disclosure of the study information 2016/01/25
Last modified on 2020/01/23

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Basic information
Public title Effectiveness of honey and expectorant for nocturnal cough in children with acute upper respiratory infection : a prospective interventional study
Acronym Effectiveness of honey for nocturnal cough in children: a prospective interventional study
Scientific Title Effectiveness of honey and expectorant for nocturnal cough in children with acute upper respiratory infection : a prospective interventional study
Scientific Title:Acronym Effectiveness of honey for nocturnal cough in children: a prospective interventional study
Region
Japan

Condition
Condition acute upper respiratory infection in children
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We verify the effectiveness of honey for nocturnal cough in children with acute upper respiratory infection compared to expectorant.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in frequency of nocturnal cough on the next day when honey or expectorant had been given prior to bedtime compared to that on the first day of presentation when no medication had been given.
Key secondary outcomes Change in severity of nocturnal cough, bothersome cough, appetite and quality of sleep at night on the next day when honey or expectorant had been given prior to bedtime compared to that on the first day of presentation when no medication had been given.
Improvement of nocturnal cough one week after when honey or expectorant had been given prior to bedtime compared to that on the first day of presentation when no medication had been given.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Honey Group:
Patients in this group take honey (5g for 2-5y, 10g for 6y-) prior to bedtime orally for a week.
Interventions/Control_2 Expectorant Group:
Patients in this group take expectorants (eg. Carbocisteine 30mg/kg/day and Ambroxol 0.9mg/kg/day) orally for a weak.
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
2 years-old <=
Age-upper limit
16 years-old >
Gender Male and Female
Key inclusion criteria 1) Patient diagnosed with acute upper respiratory infection with cough for 7 or fewer days duration.
2) nocturnal cough score 3 or more (using a 7point Likert scale)
Key exclusion criteria 1) Following medications had been given for patient on the day before or after
:Antihistamines, beta2agonists, Steroids, Leukotriene receptor antagonists
eg) asthma, atopic dermatitis, allergic rhinitis
2) Patient admitted to hospital
3) Patient with underlying disease
eg) Cerebral palsy, Congenital heart disease, Chronic lung disease, Myopathy, Malformation syndrome, Immunodeficiency
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Kazushi
Middle name
Last name Agata
Organization Tokyo Medical University Hachioji Medical Center
Division name Pediatrics
Zip code 1930998
Address 1163 Tatemachi, Hachioji, Tokyo, Japan
TEL 0426655611
Email tokyoseki2016@gmail.com

Public contact
Name of contact person
1st name Shun
Middle name
Last name Kishibe
Organization Tokyo Metropolitan Children's Medical Center
Division name Pediatric Emergency Medicine
Zip code 19309988
Address 2-8-29 Musashidai, Fuchu-shi, Tokyo, Japan
TEL 042-300-5111
Homepage URL
Email jemstone625@gmail.com

Sponsor
Institute Tokyo Medical University Hachioji Medical Center
Institute
Department

Funding Source
Organization Tokyo Medical University Hachioji Medical Center
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Hashimoto pediatric Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokyo Metropolitan Children's Medical Center
Address 2-8-29 Musashidai, Fuchu-shi, Tokyo, Japan
Tel 0423005111
Email shun_kishibe@tmhp.jp

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 東京医科大学八王子医療センター

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 25 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 No longer recruiting
Date of protocol fixation
2016 Year 01 Month 13 Day
Date of IRB
2016 Year 01 Month 13 Day
Anticipated trial start date
2016 Year 01 Month 25 Day
Last follow-up date
2017 Year 09 Month 30 Day
Date of closure to data entry
2017 Year 09 Month 30 Day
Date trial data considered complete
2018 Year 02 Month 26 Day
Date analysis concluded
2020 Year 01 Month 30 Day

Other
Other related information

Management information
Registered date
2016 Year 01 Month 20 Day
Last modified on
2020 Year 01 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023827

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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