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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039247
Receipt No. R000044748
Scientific Title A study of reducing discomfort in the eyes and nose after consuming herb powder when pollen from Cryptomeria japonica (known as sugi in Japanese) is dispersed. A double-blind, parallel group comparison study
Date of disclosure of the study information 2020/01/24
Last modified on 2020/07/21

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Basic information
Public title A study of reducing discomfort in the eyes and nose after consuming herb powder when pollen from Cryptomeria japonica (known as sugi in Japanese) is dispersed.
A double-blind, parallel group comparison study
Acronym A study of reducing discomfort in the eyes and nose after consuming herb powder when pollen from Cryptomeria japonica (known as sugi in Japanese) is dispersed.
A double-blind, parallel group comparison study
Scientific Title A study of reducing discomfort in the eyes and nose after consuming herb powder when pollen from Cryptomeria japonica (known as sugi in Japanese) is dispersed.
A double-blind, parallel group comparison study
Scientific Title:Acronym A study of reducing discomfort in the eyes and nose after consuming herb powder when pollen from Cryptomeria japonica (known as sugi in Japanese) is dispersed.
A double-blind, parallel group comparison study
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate safety and efficacy of 8-week intake of test food on discomfort in the eyes and nose (such as sneezing, runny nose, congestion, and itchy eyes) of healthy males and females (aged 20-64) caused by pollen from sugi, etc.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Nasal examination in mucosa of the inferior turbinate (swelling and color), amount of mucus fluid, and characteristics of nasal discharge.
Nasal and eye symptom survey.
Key secondary outcomes Allergy tests for non-specific IgE in the blood, non-specific IgE (sugi or cypress), and eosinophil.
The Japanese rhino-conjunctivitis quality of life questionnaire No 1 (JRQLQ No1)
An antioxidant test to detect 8-hydroxy-2'- Deoxyguanosine (8-OHdG) in urine

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 After having breakfast or in the morning, take test food along with approximately 100cc water or lukewarm water every day for 8 weeks.
Interventions/Control_2 After having breakfast or in the morning, take placebo food along with approximately 100cc water or lukewarm water every day for 8 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
20 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 1. 20 to 64 years old (at the time of submission of an informed consent document).
2. Healthy Japanese males and females.
3. Those who have symptoms, such as sneezing, runny nose, congestion, and itchy eye, caused by pollen from sugi, etc. and who are allowed to participate in this study by the principal investigator.
4. BMI below 30 kg/m2
5. Those who can take test food for 8 weeks.
6. Smartphone or PC users (who can input their own data into the electronic diary).
7. Those who can receive sufficient explanation of the purpose and content of this study, who have ability to agree with the above explanation, who voluntarily participate in this study after coming to a better understanding, and who can give written informed consent.
8. Those who are regarded as not ill and allowed to participate in this study by the principal investigator or a sub-investigator.
Key exclusion criteria 1. Those who are currently receiving some types of drug and Chinese medical treatments.
2. Those with acute rhinitis, sinusitis, nasal polyp, hypertrophic rhinitis, and deviated septum.
3. Those who had undergone intranasal surgery.
4. Those with coexisting bronchial asthma.
5. Those who have or had a severe disease of the liver, heart, kidneys, gastrointestinal tract, respiratory system, endocrine, and metabolism.
6. Those who are receiving specific hyposensitization therapy.
7. Those who take oral medication or nasal spray for antihistamines or anti-allergic drugs on a daily basis.
8. Those who take Lactobacillus preparation, supplements containing Lactobacillus, or yogurt on a daily basis.
9. Those who take food products with anti-allergic effects, such as "Tian Cha" derived from Chinese Blackberry leaves and "Memehana-cha" derived from 'Benifuki' cultivar, on a daily basis.
10. Those who may have allergic reactions to test food.
11. Those who are currently taking health food (such as supplements or food products to maintain or restore health), except for those who can temporarily stop taking the above health food at the time of submission of an informed consent document and remain the same until the end of this study.
12. Those who have a past and current medical history of drug or food allergy.
13. Those who are currently participating in another clinical trial or who had participated in another clinical trial conducted within a month prior to the submission of an informed consent document.
14. Those who are currently pregnant or breastfeeding and who want to become pregnant.
15. Heavy drinkers.
16. Smokers.
17. Those who experienced a feeling of being unwell or deterioration of health condition when they had blood drawn.
18. Those who may undergo lifestyle changes (such as a long trip) during the study period.
19. Those who were determined by the principal investigator to be unsuitable for participation in this clinical trial.
Target sample size 28

Research contact person
Name of lead principal investigator
1st name Hiroyuki
Middle name
Last name Onda
Organization S&B FOODS INC.
Division name Development and Manufacturing group,Central research institute, Technical research and development unit, Functional food research team
Zip code 174-8651
Address 38-8 ,Miyamoto-cho,Itabashi-ku, Tokyo
TEL 03-3558-5531
Email hiroyuki_onda@sbfoods.co.jp

Public contact
Name of contact person
1st name Hirokuni
Middle name
Last name Kayama
Organization imeQ RD inc.
Division name Sales department
Zip code 169-0051
Address 2-14-6, Nishi-Waseda, Shinjyuku, Tokyo
TEL 03-6205-6222
Homepage URL
Email h-kayama@imeqrd.co.jp

Sponsor
Institute imeQ RD inc.
Institute
Department

Funding Source
Organization S&B FOODS INC.
Organization
Division
Category of Funding Organization Self funding
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 03-6205-6222
Email suda-clinic_irb@imeq.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
2020 Year 01 Month 24 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 28
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
2019 Year 12 Month 13 Day
Date of IRB
2019 Year 12 Month 16 Day
Anticipated trial start date
2020 Year 01 Month 25 Day
Last follow-up date
2020 Year 03 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
2020 Year 01 Month 24 Day
Last modified on
2020 Year 07 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044748

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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