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Name
UMIN ID

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000048565
Receipt No. 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 2022/08/03

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Basic information
Public title Effects on allergic reaction of eyes and nose in healthy Japanese subjects
Acronym Effects on allergic reaction of eyes and nose in healthy Japanese subjects
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
Scientific Title:Acronym Effects of consumption of the test food on allergic reaction of eyes and nose in healthy Japanese subjects
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 on allergic reaction of eyes and nose in healthy Japanese subjects
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1. The score of Japanese rhino-conjunctivitis quality of life questionnaire (JRQLQ)
Key secondary outcomes 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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 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.
Interventions/Control_2 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.
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 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.
Key exclusion criteria 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
Target sample size 10

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
Email 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
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization Kawabata Inc.
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
Email 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
2022 Year 08 Month 03 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
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 Open public recruiting
Date of protocol fixation
2022 Year 07 Month 20 Day
Date of IRB
2022 Year 07 Month 20 Day
Anticipated trial start date
2022 Year 08 Month 03 Day
Last follow-up date
2022 Year 12 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 08 Month 03 Day
Last modified on
2022 Year 08 Month 03 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055340

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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