Unique ID issued by UMIN | UMIN000033708 |
---|---|
Receipt number | R000038432 |
Scientific Title | A verification study of improving on allergy-like symptoms to impacts on daily life with consumption of the test food containing fermented black jabara (Citrus jabara) in healthy Japanese subjects: a randomized, double-blind, placebo-controlled, parallel-group trial |
Date of disclosure of the study information | 2018/08/10 |
Last modified on | 2019/08/16 09:09:41 |
A verification study of improving on allergy-like symptoms to impacts on daily life with consumption of the test food containing fermented black jabara (Citrus jabara) in healthy Japanese subjects: a randomized, double-blind, placebo-controlled, parallel-group trial
A verification study of improving on allergy-like symptoms to impacts on daily life with consumption of the test food containing fermented black jabara (Citrus jabara)
A verification study of improving on allergy-like symptoms to impacts on daily life with consumption of the test food containing fermented black jabara (Citrus jabara) in healthy Japanese subjects: a randomized, double-blind, placebo-controlled, parallel-group trial
A verification study of improving on allergy-like symptoms to impacts on daily life with consumption of the test food containing fermented black jabara (Citrus jabara)
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To verify the effects of consumption of the test food containing fermented black jabara (Citrus jabara) for 4 weeks on allergy-like symptoms to impacts on daily life in healthy Japanese subjects with discomfort in their eyes and nose.
Efficacy
Confirmatory
Pragmatic
Not applicable
Japanese rhino-conjunctivitis quality of life questionnaire (JRQLQ No1)
* Assess the items at screening (before consumption) and 4 weeks after consumption.
1. Questionnaire based on practical guideline for the management of allergic rhinitis in Japan (record in the diary report)
sneezing, runny nose, blocked nose, itchy eyes, and watery eyes
2. Specific IgE (Dermatophagoides pteronyssinus, animal dander, Japanese red-cedar, orchard grass, timothy grass, ragweed, and moth)
3. Eosinophils in the nasal discharge
*1 Record the daily report every day from 1 week before starting consumption.
*2, 3 Assess the items at screening (before consumption) and 4 weeks after consumption.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Food |
Duration: 4 weeks
Test Material: Active capsule
Dosage: Take 3 capsules any time during the day with water or warm water
* If you forget to take the capsules, take capsules as soon as you remember within the day.
Duration: 4 weeks
Test Material: Placebo capsule
Dosage: Take 3 capsules any time during the day with water or warm water
* If you forget to take the capsules, take capsules as soon as you remember within the day.
20 | years-old | <= |
Not applicable |
Male and Female
1. Healthy Japanese adult subjects
2. Subjects who are experiencing discomfort in their eyes and nose
3. Subjects who are judged as eligible to participate in the study by the physician
4. Within the subjects who met the 1st to 3rd inclusion criteria, subjects whose total QOL score of JRQLQ No1 is relatively high at screening (before consumption)
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction
2. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
3. Subjects who are diagnosed with pollen allergy
4. Subjects who are diagnosed with allergic rhinitis
5. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily
6. Subjects who are currently taking medications (including herbal medicines) and supplements
7. Subjects who could have an allergy to raw materials of the test food, or possible to have serious allergic reactions to other foods and/or medicines
8. Subjects who are pregnant, lactation, or planning to become pregnant
9. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial
10. Subjects who are judged as ineligible to participate in the study by the physician
16
1st name | Kazuo |
Middle name | |
Last name | YAMAMOTO |
ORTHOMEDICO Inc.
CEO
112-0002
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
03-3818-0610
kazu@orthomedico.jp
1st name | Naoko |
Middle name | |
Last name | SUZUKI |
ORTHOMEDICO Inc.
R&D Department
112-0002
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO Inc.
Nisshin Honey co.,ltd.
Profit organization
Medical Corporation Seishinkai, Takara Clinic
The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
03-5793-3623
info@takara-clinic.com
NO
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)
2018 | Year | 08 | Month | 10 | Day |
Unpublished
18
Completed
2018 | Year | 08 | Month | 06 | Day |
2018 | Year | 08 | Month | 06 | Day |
2018 | Year | 08 | Month | 20 | Day |
2018 | Year | 11 | Month | 24 | Day |
2018 | Year | 08 | Month | 10 | Day |
2019 | Year | 08 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038432
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |