UMIN-CTR Clinical Trial

Public title

Verification for the effects of consumption of the test food on allergy-like symptoms

Acronym

Verification for the effects of consumption of the test food on allergy-like symptoms

Scientific Title

Verification for the effects of consumption of the test food on allergy-like symptoms: A randomized, double-blind, placebo-controlled, parallel-group comparison trial

Scientific Title:Acronym

Verification for the effects of consumption of the test food on allergy-like symptoms

Region

Japan

Condition

Healthy Japanese subjects

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To verify the effects of consumption of the test food for eight weeks on the efficacy on the eye and nose discomfort caused by cedar pollen etc. (sneezing, runny nose, blocked nose, and itchy eyes etc.), and the safety in healthy Japanese subjects aged 20 or more and less than 65.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

1. The measured value and change from screening of each score of the Japanese Rhino-conjunctivitis Quality of Life Questionnaire (JRQLQ) at four and eight weeks after consumption (4w and 8w)

2. The measured value of each question item of JRQLQ at 4w and 8w

3. The measured value of the questionnaire based on practical guideline for the management of allergic rhinitis in Japan at 4w and 8w

Key secondary outcomes

1. The measured values and changes from screening of serum specific IgE levels (Japanese red-cedar, cypress, house dust, and Dermatophagoides pteronyssinus), eosinophils count in nasal discharge, and serum basophils counts and eosinophil cationic protein (ECP) levels at 4w and 8w

2. The swelling of nasal mucosa at 4w and 8w

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Duration: Eight weeks
Test food: Plant extract
Administration: Take two capsules per day (one capsule each after breakfast and dinner) with water

*If you forget to take the test food, take it as soon as you remember within the day.

Interventions/Control_2

Duration: Eight weeks
Test food: Placebo
Administration: Take two capsules per day (one capsule each after breakfast and dinner) with water

*If you forget to take the test food, take it as soon as you remember within the 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

Age-lower limit

20

years-old

<=

Age-upper limit

65

years-old

>

Gender

Male and Female

Key inclusion criteria

1. Healthy Japanese adult subjects aged 20 or more and less than 65 at the agreement to participate in this trial
2. Subjects with eye and nose discomfort
3. Subjects who are judged as eligible to participate in the study by the physician
4. Subjects who are positive specific IgE test against Japanese red-cedar, cypress, house dust, or Dermatophagoides pteronyssinus at screening
5. Subjects who have relatively high score in the total score of JRQLQ at the point of screening
6. Among the healthy subjects and those with mild symptoms, more than half of the enrolled subjects will be selected from healthy subjects.

a. Healthy subjects:
1. Subjects suffering or having suffered from allergic reactions in their eyes and nose
2. Subjects not using antiallergic drugs before and during the trial

b. Subjects with mild symptoms:
1. Subjects suffering or having suffered from allergic reactions in their eyes and nose
2. Subjects who sometimes (not regularly) used antiallergic drugs before and during this trial
* "Sometimes" means using a drug as needed.
* "Regularly use" means using a drug at fixed intervals even if there are no symptoms.

Key exclusion criteria

Subjects who (are)
1.undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2.have a pacemaker or an implantable cardioverter defibrillator
3.currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver, kidney, or cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4.currently being treated with any kind of drug or herbal medicine (except for single use)
5.have acute rhinitis, sinusitis, nasal polyp, hypertrophic rhinitis, or nasal septum deviation
6.have undergone nasal surgery (coagulation necrosis, excision, etc.) in the past
7.with concomitant bronchial asthma
8.have a symptom or a history of a serious liver, cardiac, renal, gastrointestinal, respiratory, endocrine, or metabolic disease (except for appendicitis)
9.undergoing specific hyposensitization
10.currently taking an oral or nasal antihistamine or antiallergic medication
11.take lactobacillus preparation and/or supplements or yogurt in daily use
12.take foods with antiallergic effects such as sweet tea, memehana tea etc. in daily use
13.take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily use
14.currently taking medications (including herbal medicines) and supplements
15.have a past or current medical history of allergies to medicines and/or foods
16.have a risk of allergies to the test food
17.have been enrolled in other clinical trials within the last 3 months before the agreement to participate in this trial or plan to participate another trial during this trial
18.pregnant, breast-feeding, or planning to become pregnant
19.drink alcohol immoderately
20.smokers
21.have experienced sick or deteriorated health after blood sampling in the past
22.may change their lifestyles, such as long trips, during this trial
23.judged as ineligible to participate in the study by the physician

Target sample size

40

Name of lead principal investigator

1st name	Tsuyoshi
Middle name
Last name	Takara

Organization

Medical Corporation Seishinkai, Takara Clinic

Division name

Director

Zip code

141-0022

Address

9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan

TEL

03-5793-3623

Email

t-takara@takara-clinic.com

Name of contact person

1st name	Naoko
Middle name
Last name	Suzuki

Organization

ORTHOMEDICO Inc.

Division name

R&D Department

Zip code

112-0002

Address

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.

TEL

03-3818-0610

Homepage URL

Email

nao@orthomedico.jp

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name

Organization

Oryza Oil & Fat Chemical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Medical Corporation Seishinkai, Takara Clinic

Nerima Medical Association, Minami-machi Clinic

Name of secondary funder(s)

Organization

the ethical committee of the Takara Clinic, Medical Corporation Seishinkai

Address

9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.

Tel

03-5793-3623

Email

IRB@takara-clinic.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)

Date of disclosure of the study information

2021

Year

05

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

44

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

2020

Year

11

Month

11

Day

Date of IRB

2020

Year

11

Month

11

Day

Anticipated trial start date

2020

Year

11

Month

27

Day

Last follow-up date

2021

Year

04

Month

17

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2020

Year

11

Month

27

Day

Last modified on

2024

Year

04

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048589