UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039533 |
|---|---|
| Receipt number | R000045039 |
| Scientific Title | Effects of umesu phenolics on the prevention of common cold and influenza (placebo-controlled trial) |
| Date of disclosure of the study information | 2020/02/21 |
| Last modified on | 2020/02/19 14:00:01 |
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Basic information
Public title
Effects of umesu polyphenol on the prevention of common cold and influenza (placebo-controlled trial)
Acronym
UPPCI
Scientific Title
Effects of umesu phenolics on the prevention of common cold and influenza (placebo-controlled trial)
Scientific Title:Acronym
UPPCI
Region
| Japan |
Condition
Condition
common cold, influenza
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Umesu phenolics (UPs), industrially derived from a by-product of the mume fruit (Japanese apricot), are composed of hydroxycinnamic acid derivatives. UPs inhibit the multiplication of common cold and influenza viruses and have virucidal effects. We conducted a clinical trial to examine the effects of gargling with UPs on the incidence of common cold and influenza in healthy subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The incidence and duration of common cold/influenza over the full 9-week trial period. The incidence and duration of common cold and influenza symptomatic days by week.
Key secondary outcomes
The incidence and duration of common cold and influenza symptoms(runny nose, sneezing, sore throat/throat discomfort (irritation), headache, cough, expectoration, fever, joint pain, and fatigue/malaise) over the full 9-week trial period. The incidence and duration of common cold and influenza symptoms by week.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Two groups: a group that gargled with granules containing UPs (UP group) and a group that gargled with granules not containing UPs (placebo group).
Interventions/Control_2
The 2 g/packet UP granules used in the present study contained 125 mg UPs and were dissolved in 100 mL water to achieve a gargle with a UP concentration of 1.25 mg/mL. The 2 g/packet placebo granules did not contain UPs. Participants gargled with the granules dissolved water three times a day for 9 weeks.
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
| 16 | years-old | < |
Age-upper limit
| 66 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Halthy volanteers
Key exclusion criteria
Those with serious somatic disorders including cerebrovascular disease, ischemic heart disease, cancer, and diabetes mellitus, and those who were pregnant.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Takahiko |
| Middle name | |
| Last name | Mitani |
Organization
Wakayama University
Division name
Research Center for Food and Agriculture
Zip code
640-8510
Address
930 Sakaedani, Wakayama, Wakayama
TEL
+81-73-457-7562
tmitani@wakayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Takahiko |
| Middle name | |
| Last name | Mitani |
Organization
Wakayama University
Division name
Research Center for Food and Agriculture
Zip code
640-8510
Address
930 Sakaedani, Wakayama, Wakayama
TEL
+81-73-457-7562
Homepage URL
tmitani@wakayama-u.ac.jp
Sponsor or person
Institute
Wakayama University
Institute
Department
Personal name
Funding Source
Organization
The Kishu-Tanabe Ume Promotion Committee
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Wakayama University
Address
930 Sakaedani, Wakayama, Wakayama
Tel
+81-73-457-7562
tmitani@wakayama-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | Month | 21 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Unpublished
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
300
Results
After 9 weeks of gargling, common cold/influenza incidence in the UP group and placebo group were 13.3% and 13.6%, respectively, showing no significant difference. Gargling with UPs was estimated to significantly shorten the number of symptomatic days per incidence by approximately 3 days at 9 th week. The number of days on which sneezing occurred was significantly (p < 0.05) lower in the UP group.
Results date posted
| 2020 | Year | 02 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The baseline characteristics of the participants are summarized as below. The two groups did not demonstrate any differences in sex, age, current illnesses, medical history (hypertension, diabetes, etc.), regular gargling (yes or no), or type of gargle used. Influenza vaccination was significantly less common in the placebo group.
Participant flow
The 300 participants, 149 were in the placebo group, while 151 were in the UP group. Five participants in the placebo group discontinued the trial due to circumstances unrelated to the trial itself (change of residence, change of job, etc.).
Adverse events
No notable adverse events were observed in either group during or after the trial period.
Outcome measures
Outcomes consisted of the following: incidence and duration of common cold/influenza, and incidence and duration of common cold/influenza symptoms, i.e., runny nose, sneezing, sore throat/throat discomfort (irritation), headache, cough, expectoration, fever, joint pain, and fatigue/malaise. For incidence of common cold/influenza and their symptoms, the mean weekly incidence rate was used as an assessment indicator. For duration of common cold/influenza and their symptoms (symptomatic days), the mean number of days per week was used as an assessment indicator. These assessment indicators were compared between the placebo group and UP group for the overall 9-week period and on a weekly basis.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 09 | Month | 29 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 19 | Day |
Last modified on
| 2020 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045039
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