UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056713 |
|---|---|
| Receipt number | R000064678 |
| Scientific Title | Evaluation of the Efficacy of Harb Powder Intake for Alleviating Nasal Discomfort During Cedar Pollen Dispersal - A Randomized Double-Blind Placebo-Controlled Parallel-Group Comparison Study |
| Date of disclosure of the study information | 2025/01/14 |
| Last modified on | 2025/01/14 17:38:14 |
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Basic information
Public title
Evaluation of the Efficacy of Harb Powder Intake for Alleviating Nasal Discomfort During Cedar Pollen Dispersal - A Randomized Double-Blind Placebo-Controlled Parallel-Group Comparison Study
Acronym
Evaluation of the Efficacy of Harb Powder Intake for Alleviating Nasal Discomfort During Cedar Pollen Dispersal
Scientific Title
Evaluation of the Efficacy of Harb Powder Intake for Alleviating Nasal Discomfort During Cedar Pollen Dispersal - A Randomized Double-Blind Placebo-Controlled Parallel-Group Comparison Study
Scientific Title:Acronym
Evaluation of the Efficacy of Harb Powder Intake for Alleviating Nasal Discomfort During Cedar Pollen Dispersal
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the efficacy and safety of a study food for 14 weeks in alleviating nasal and ocular discomfort (sneezing, runny nose, nasal congestion, itchy eyes) caused by cedar pollen in healthy male and female adults.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Nasal Symptom Score of JRQLQ
Key secondary outcomes
Eye Symptom Score and Quality of Life (QOL) Score of JRQLQ
Nasal Cavity Evaluation (inferior turbinate mucosal swelling, color of inferior turbinate mucosa, watery secretion volume, nasal discharge properties)
Specific IgE (Cedar, Cypress), Non-specific IgE
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Participants will consume 12 study food tablets daily with approximately 100 ml of water or lukewarm water every day for 14 weeks after breakfast or in the morning.
Interventions/Control_2
Participants will consume 12 control food tablets daily with approximately 100 ml of water or lukewarm water every day for 14 weeks after breakfast or in the morning.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Age: 20 to 65 years (at time of consent)
2. Gender: Japanese males and females
3. BMI less than 30 kg/m^2
4. Individuals with nasal symptoms caused by cedar pollen (sneezing, runny nose, nasal congestion) deemed suitable for participation by the principal investigator
5. Individuals not taking or only occasionally taking allergy medications before and during the study. Occasional users should be less than half of all participants.
6. Individuals able to cooperate with the study food intake for 14 weeks
7. Individuals able to input electronic diaries via smartphone or PC
8. Individuals who have received sufficient explanation about the study's purpose and content, understood it well, voluntarily agreed to participate, and provided written consent
9. Individuals deemed healthy and suitable for the study by the principal investigator
Key exclusion criteria
1. Currently under medical treatment (occasional use permitted)
2. Acute rhinitis, sinusitis, nasal polyps, or deviated nasal septum
3. History of nasal surgery
4. Bronchial asthma
5. Severe liver, kidney, heart, respiratory, endocrine, or metabolic diseases (except appendicitis)
6. Undergoing specific desensitization therapy
7. Regular intake of lactic acid bacteria products (3+ days/week), unless discontinued during the study
8. Regular intake of anti-allergic foods like sweet tea or Benifuuki tea (3+ days/week) unless ceasing during the study
9. Regular intake of foods or supplements claimed to have health benefits unless discontinued during the study
10. Allergic reactions to the study food
11. History of drug or food allergies
12. Excessive alcohol consumption (40g+ pure alcohol/day)
13. Smoking habits (less than 1 year of cessation)
14. Shift work with night shifts
15. Planning significant lifestyle changes during the study
16. Planning travel abroad during the study
17. Pregnant, breastfeeding, or planning pregnancy during the study
18. Participation in another clinical study within 1 month before consent or currently participating or planning to participate during the study
19. History of discomfort or health deterioration from blood sampling
20. Considered unsuitable for the study by the principal investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Onda |
Organization
S&B FOODS INC.
Division name
Functional food Research and Development Unit, Central Research Institute
Zip code
136-0082
Address
#605 Mitsui Link-Lab, Shinkiba 1, 2-3-8 Shinkiba, Koto-ku, Tokyo 136-0082, Japan
TEL
03-3558-5531
hiroyuki_onda@sbfoods.co.jp
Public contact
Name of contact person
| 1st name | Hirokuni |
| Middle name | |
| Last name | Kayama |
Organization
IMEQRD Co., Ltd.
Division name
Planning and Sales Department
Zip code
104-0061
Address
Daiwa Ginza Bld. 3F, 6-2-1, Ginza, Chuo-ku, Tokyo, Japan
TEL
0367045968
Homepage URL
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
S&B FOODS INC.
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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
0367045968
jimukyoku@imeqrd.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
| 2025 | Year | 01 | Month | 14 | 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
| 2024 | Year | 12 | Month | 03 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 14 | Day |
Last modified on
| 2025 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064678
