UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020651 |
|---|---|
| Receipt number | 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 | 2024/02/05 12:06:58 |
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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
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
jemstone625@gmail.com
Sponsor or person
Institute
Tokyo Medical University Hachioji Medical Center
Institute
Department
Personal name
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
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
| 2024 | Year | 03 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 20 | Day |
Last modified on
| 2024 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023827
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| Registered date | File name |
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