Tokyo, Jan. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060320) titled 'Verification of the effect of honey intake on improving cough sensitivity in humans' on Jan. 15.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Shiba Palace Clinic
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To verify the effect of honey intake on improving cough sensitivity
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - To intake honey single time
Interventions/Control_2 - To intake placebo single time
Eligibility:
Age-lower limit - 20
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 Size - 100
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068958
Disclaimer: Curated by HT Syndication.