UMIN-CTR Clinical Trial

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

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

imeQ RD inc.

Institute

Department

Personal name

Organization

S&B FOODS INC.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2020

Year

01

Month

24

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2020

Year

01

Month

24

Day

Last modified on

2020

Year

07

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044748