UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049884 |
|---|---|
| Receipt number | R000056812 |
| Scientific Title | A study to evaluate eye and nose discomfort: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2023/06/01 |
| Last modified on | 2023/06/26 11:59:15 |
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Basic information
Public title
A study to evaluate eye and nose discomfort: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Acronym
A study to evaluate eye and nose discomfort
Scientific Title
A study to evaluate eye and nose discomfort: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
A study to evaluate eye and nose discomfort
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of consumption of the test food on the discomfort of the eye and nose in healthy Japanese subjects
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. The Japanese allergic rhinitis quality of life questionnaire
2. The grading severity of allergic rhinitis questionnaire
Key secondary outcomes
1. Local findings in nasal cavity
2. Cedar pollen-specific IgE antibody levels
3. Eosinophils, LD(IFCC)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: 12 weeks
Test food: Tablet containing lactic acid bacilli
Administration: Take two tablets daily at any time with water or lukewarm water
*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.
Interventions/Control_2
Duration: 12 weeks
Test food: Tablet not containing lactic acid bacilli
Administration: Take two tablets daily at any time with water or lukewarm water
*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men or women
3. Adults
4. Healthy subjects or those with mild cedar pollen subjects
5. Subjects who have had various symptoms of cedar pollinosis (sneezing, runny nose, stuffy nose, or itchy eyes) in the past two years
6. Subjects who have not developed cedar pollinosis at the time of obtaining consent
7. Subjects who have received a sufficient explanation of the purpose and content of the study, have the ability to consent, have a good understanding of the subject, voluntarily apply for participation, and agree in writing to participate in the study
Key exclusion criteria
1. Subjects receiving treatment for perennial rhinitis
2. Subjects undergoing specific sensitization therapy or surgical therapy for hay fever
3. Subjects who use or take steroidal drugs for drug treatment of hay fever
4. Subjects who reported nasal disease (acute or chronic rhinitis, sinusitis, rhinophyma, hypertrophic rhinitis, or nasal septal deformity)
5. Subjects who have been reported as severe or most severely ill in the severity assessment of allergic rhinitis
6. Subjects suffering from certain diseases except hay fever and receiving outpatient medication
7. Subjects with a history or current history of serious hepatic disorder, renal disorder, cardiac disease, or severe anemia
8. Subjects with a current history of bronchial asthma or those taking anti-allergy medication for atopic dermatitis, asthma, etc.
9. Subjects who may show allergic symptoms to any of the research food ingredients
10. Subjects who who take medicines (such as lactobacillus preparations) that may affect test results, or who routinely consume health foods
11. Subjects with gastrointestinal diseases affecting digestion and absorption, and persons with a history of gastrointestinal surgery
12. Subjects who habitually drink excessive amounts of alcohol, exceeding approximately 60 g of pure alcohol equivalent per day, five or more days per week
13. Subjects with extremely irregular eating habits, shift workers, late-night workers, or those with irregular life rhythms
14. Pregnant, lactating, or intending to become pregnant
15. Subjects who have donated more than 200 mL of blood or component blood within 4 weeks of the screening test or 400 mL within 3 months of the screening test
16. Subjects who have participated in other studies within 1 month of obtaining consent, and those who are willing to participate
17. Subjects who are judged as ineligible to participate in this study by the physician
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Tohru |
| Middle name | |
| Last name | Sagami |
Organization
Doctor
Division name
Shinagawa Season Terrace Health Care Clinic
Zip code
108-0075
Address
1-2-70, Konan, Minato-ku, Tokyo. The 5th floor of Shinagawa season terrace
TEL
03-3452-3382
shibaura@sempos.or.jp
Public contact
Name of contact person
| 1st name | Yoshika |
| Middle name | |
| Last name | Komori |
Organization
KSO Corporation
Division name
Clinical Trial Management department
Zip code
105-0023
Address
1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
Asahi Group Foods, Ltd.
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
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17 Joto-machi, Maebashi-shi, Gumma
Tel
027-212-5608
sagawa@mc-connect.co.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
| 2023 | Year | 06 | Month | 01 | 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
Completed
Date of protocol fixation
| 2022 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 23 | Day |
Last modified on
| 2023 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056812
