UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042583 |
|---|---|
| Receipt number | R000048589 |
| 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 |
| Date of disclosure of the study information | 2021/05/31 |
| Last modified on | 2024/04/03 10:22:46 |
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Basic information
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
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Assessment
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
Base
Study type
Interventional
Study design
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
Intervention
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
Eligibility
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
Research contact person
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
t-takara@takara-clinic.com
Public contact
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
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
Oryza Oil & Fat Chemical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
Name of secondary funder(s)
IRB Contact (For public release)
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
IRB@takara-clinic.com
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
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)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 31 | 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
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
Progress
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
Other related information
Management 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
