UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060320 |
|---|---|
| Receipt number | R000068958 |
| Scientific Title | Verification of the effect of honey intake on improving cough sensitivity in humans |
| Date of disclosure of the study information | 2026/01/15 |
| Last modified on | 2026/01/10 20:13:15 |
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Basic information
Public title
Verification of the effect of honey intake on improving cough sensitivity in humans
Acronym
Verification of the effect of honey intake on improving cough sensitivity
Scientific Title
Verification of the effect of honey intake on improving cough sensitivity in humans
Scientific Title:Acronym
Verification of the effect of honey intake on improving cough sensitivity
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect of honey intake on improving cough sensitivity
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cough threshold in the capsaicin cough sensitivity test
Japanese Newcastle Laryngeal Hypersensitivity Questionnaire(J-NLHQ)
VAS questionnaire
Key secondary outcomes
subjects' diary
doctor's findings according to the subjects' diary
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
To intake honey single time
Interventions/Control_2
To intake placebo single time
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Japanese males and females aged 20 to 64 years old at the time of informed consent
2) Healthy adults
3) Subjects who are concerned about coughing or throat discomfort
4) Subjects who regularly eat three meals a day
5) Subjects who Subjects who can perform informed consent
6) Subjects who can understand and comply with the management instructions during the study period
Key exclusion criteria
1) Subjects who regularly consume honey
2) Subjects unable to maintain a regular daily routine
3) Pregnant, intending to become pregnant, or breastfeeding
4) Subjects participating in other clinical tests or studies during the test period
5) Subjects who are supposed not to be proper by the investigator
6) Subjects planning medication treatment for hay fever during the test period
7) Subjects unable to discontinue medications that may affect test results (e.g., cough suppressants, cold remedies, allergy suppressants) 7 days prior to the test
8) Subjects at risk of allergic reactions to test components (honey, chili pepper extract)
9) Subjects planning to change their diet during the test period
10) Subjects with cardiovascular or respiratory diseases, asthma, severe allergic diseases, liver dysfunction, kidney or heart disease, organ dysfunction, diabetes, or other serious illnesses
11) Subjects with a history of major gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, intestinal resection, etc.)
12) Subjects who consume excessive amounts of alcohol (equivalent to 20g of pure alcohol or more per day)
13) Smokers (or individuals living with smokers)
14) Subjects experiencing hay fever symptoms during the test period
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Koikeda |
Organization
Shiba Palace Clinic
Division name
Chair
Zip code
105-0013
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL
03-5408-1590
rinri@s-palace-clinic.com
Public contact
Name of contact person
| 1st name | Ko |
| Middle name | |
| Last name | Masuda |
Organization
SOUKEN Co., Ltd
Division name
Management Division
Zip code
105-0013
Address
DaiwaA Hamamatsucho Bldg. 3F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL
03-5408-1555
Homepage URL
rinri@s-palace-clinic.com
Sponsor or person
Institute
Shiba Palace Clinic
Institute
Department
Personal name
Funding Source
Organization
Yamada Bee Farm
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
03-5408-1599
rinri@s-palace-clinic.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
| 2026 | Year | 01 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 12 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 10 | Day |
Last modified on
| 2026 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068958
