Unique ID issued by UMIN | UMIN000048565 |
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Receipt number | R000055340 |
Scientific Title | Effects of consumption of the test food on allergic reaction of eyes and nose in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
Date of disclosure of the study information | 2022/08/03 |
Last modified on | 2022/09/22 11:36:23 |
Effects on allergic reaction of eyes and nose in healthy Japanese subjects
Effects on allergic reaction of eyes and nose in healthy Japanese subjects
Effects of consumption of the test food on allergic reaction of eyes and nose in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Effects of consumption of the test food on allergic reaction of eyes and nose in healthy Japanese subjects
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To verify the effects of consumption of the test food on allergic reaction of eyes and nose in healthy Japanese subjects
Efficacy
Confirmatory
Pragmatic
Not applicable
1. The score of Japanese rhino-conjunctivitis quality of life questionnaire (JRQLQ)
1. Each item of JRQLQ
2. Each item of the severity classification of allergic rhinitis
3. Non-specific immunoglobulin E (IgE), specific IgE (house dust and mite), and eosinophils in nasal discharge
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
Institution is not considered as adjustment factor.
2
Treatment
Food |
Duration: 12 weeks
Test food: Capsule containing the pineneedle extract
Administration: Take eight capsules with water before breakfast
* Daily dose should be taken within the day. If you forget to take the test food, take it as soon as you remember within the day and do not carry it over to the next day.
Duration: 12 weeks
Test food: Placebo capsule
Administration: Take eight capsules with water before breakfast
* Daily dose should be taken within the day. If you forget to take the test food, take it as soon as you remember within the day and do not carry it over to the next day.
18 | years-old | <= |
Not applicable |
Male and Female
1. Japanese
2. Men or women
3. Adults
4. Healthy subjects
5. Subjects who have subjective symptoms of allergic rhinitis (such as sneezing, runny nose, stuffy nose, or itchy eyes) at last two years
6. Subjects whose eyes and nose allergic reaction based on results of the background investigation questionnaire at screening (before consumption; Scr) is worse than other subjects
*Among the healthy subjects and those with mild symptoms, more than half of the enrolled subjects will be selected from healthy subjects.
(i) Healthy subjects
who have eyes and nose discomfort by pollen at last two years and do not use antiallergic drugs
(ii) Subjects with mild symptoms
who have eyes and nose discomfort by pollen at last two years and sometimes (not regularly) use antiallergic drugs
*"Sometimes" means using a drug as needed.
*"Regularly use" means using a drug at fixed intervals even if there are no symptoms.
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily
5. Subjects who take functional food/beverage that may affect allergic reaction, such as beta-carotene, methylated catechins, lactic acid bacteria, bifidobacteria, rosmarinic acid, acetic acid bacteria, soy fermented polysaccharides, caffeic acid, luteolin, quercetin, hesperidin, or nobiletin at least four times a week
6. Subjects who drink to excess (average of more than about 20 g/day as absolute alcohol intake) {500 mL: a medium bottle of beer or about 1.5 cans of canned chu-hi, 180 mL: 1 go of sake or about 1.5 glasses of wine, 90 mL: half-go with shochu, 60 mL: a glass of whiskey brandy (double)}
7. Subjects who are currently taking medications (including herbal medicines) and supplements
8. Subjects who are receiving long-term drug treatment (antiallergic drugs, antihistamines, steroids, vasoconstrictors, antihypertensives, etc.) that may affect allergic symptoms of the nose and eyes during the trial
9. Subjects who are allergic to medicines and/or the test food related products
10. Subjects who are pregnant, lactation, or planning to become pregnant during this trial
11. Subjects who suffer from COVID-19
12. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial
13. Subjects who are judged as ineligible to participate in this study by the physician
10
1st name | Tsuyoshi |
Middle name | |
Last name | Takara |
Medical Corporation Seishinkai, Takara Clinic
Director
141-0022
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
03-5793-3623
t-takara@takara-clinic.com
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.
Kawabata Inc.
Profit organization
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi 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
IRB@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)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
2022 | Year | 08 | Month | 03 | Day |
Unpublished
10
No longer recruiting
2022 | Year | 07 | Month | 20 | Day |
2022 | Year | 07 | Month | 20 | Day |
2022 | Year | 08 | Month | 03 | Day |
2022 | Year | 12 | Month | 23 | Day |
2022 | Year | 08 | Month | 03 | Day |
2022 | Year | 09 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055340
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