UMIN-ICDS Clinical Trial

Public title

Efficacy Evaluation of the Alleviating Effect of Coriander Powder Intake on Nasal Discomfort during Cedar Pollen Dispersion - A Randomized, Double-blind, Placebo-Controlled Parallel Group Comparative Trial-

Acronym

Efficacy Evaluation of the Alleviating Effect of Coriander Powder Intake on Nasal Discomfort during Cedar Pollen Dispersion

Scientific Title

Efficacy Evaluation of the Alleviating Effect of Coriander Powder Intake on Nasal Discomfort during Cedar Pollen Dispersion - A Randomized, Double-blind, Placebo-Controlled Parallel Group Comparative Trial-

Scientific Title:Acronym

Efficacy Evaluation of the Alleviating Effect of Coriander Powder Intake on Nasal Discomfort during Cedar Pollen Dispersion

Region

Japan

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim is to evaluate the effectiveness and safety against nasal and eye discomfort (sneezing, runny nose, nasal congestion, eye itchiness, etc.) caused by cedar pollen, by having male and female healthy subjects with nasal symptoms such as sneezing, runny nose, and nasal congestion caused by cedar pollen, ingest the research food for 8 weeks.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

JRQLQ Nasal Symptom Score

Key secondary outcomes

- JRQLQ Eye Symptom Score and QOL (Quality of Life) Score
- Nasal Cavity Evaluation (Expansion of inferior nasal concha mucosa, Color tone of inferior nasal concha mucosa, Watery secretion amount and nasal fluid properties)
- Cedar-specific IgE, Non-specific IgE

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

Consume 12 capsules/day of the test food every day for 8 weeks, accompanied by about 100 mL of water or lukewarm water, after breakfast or in the morning.

Interventions/Control_2

Consume 12 capsules/day of the placebo food every day for 8 weeks, accompanied by about 100 mL of water or lukewarm water, 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

Age-lower limit

20

years-old

<=

Age-upper limit

65

years-old

>

Gender

Male and Female

Key inclusion criteria

Age: 20 or above and under 65 (at the time of consent).
2. Gender: Japanese nationality males and females.
3. Those who have nasal symptoms such as sneezing, runny nose, and nasal congestion caused by cedar pollen, but are judged by the research physician to have no problem participating in this trial.
4. Those who do not "take" or "sometimes take but do not regularly take" allergy medications before and during the research: Those who sometimes take are to be less than half of all subjects.
5. Those with a BMI less than 30 kg/m^2.
6. Those who can cooperate in taking the research food for 8 weeks.
7. Those who can enter electronic diaries via smartphones or PCs.
8. Those who have received a sufficient explanation about the purpose and content of this trial, have the ability to consent, understand well, voluntarily wish to participate, and can consent in writing to participate in this research.
9. Those who are judged by the research physician to not be patients and are deemed suitable to participate in this trial.

Key exclusion criteria

1. Those currently receiving medical treatment or treatment with medicines or Kampo for any disease (intermittent use is acceptable).
2. Those with acute rhinitis, sinusitis, nasal polyps, deviated nasal septum, etc..
3. Those who have undergone nasal cavity surgery.
4. Those with bronchial asthma.
5. Those who have or had serious liver, kidney, heart, respiratory, endocrine, metabolic diseases, etc. (appendicitis is acceptable).
6. Those undergoing specific desensitization therapy.
7. Those who regularly consume lactic acid bacteria products, lactic acid bacteria supplements, and yogurt (3 or more times a week) (those who can suspend consumption during the study period are acceptable).
8. Those who regularly consume foods with anti-allergy effects such as sweet tea and benifuuki tea (3 or more times a week) (those who can suspend consumption during the study period are acceptable).
9. Those who may have allergic symptoms to the research food.
10. Those who consume healthy foods (foods or supplements aimed at maintaining or recovering health) (those who can suspend consumption during the study period are acceptable).
11. Those with a current or past history of drug allergy or food allergy.
12. Those who have participated in other clinical trials within one month before consent acquisition or are currently participating.
13. Those who are currently pregnant or breastfeeding, and those who wish to become pregnant.
14. Those with excessive drinking habits exceeding about 40 g of pure alcohol per day.
15. Those with smoking habits (less than one year after quitting).
16. Those with shift work including night shifts.
17. Those who have experienced discomfort or deterioration of physical condition due to blood collection in the past.
18. Those who may change their lifestyle during the study period, such as long-term travel.
19. Others whom the research physician judges to be inappropriate as subjects of this trial.

Target sample size

60

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

Email

hiroyuki_onda@sbfoods.co.jp

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

Email

clinical-trial@imeqrd.co.jp

Institute

S&B FOODS INC.

Institute

Department

Personal name

Organization

S&B FOODS INC.

Organization

Division

Category of Funding Organization

Profit organization

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

0367045968

Email

n-yuzawa@imeqrd.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

2024

Year

02

Month

09

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

No longer recruiting

Date of protocol fixation

2023

Year

12

Month

19

Day

Date of IRB

2023

Year

12

Month

26

Day

Anticipated trial start date

2024

Year

02

Month

10

Day

Last follow-up date

2024

Year

04

Month

07

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2024

Year

01

Month

16

Day

Last modified on

2024

Year

02

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060902