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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033708
Receipt No. R000038432
Official scientific title of the study 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 2018/10/12

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Basic information
Official scientific title of the study 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
Title of the study (Brief 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)
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 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.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Japanese rhino-conjunctivitis quality of life questionnaire (JRQLQ No1)

* Assess the items at screening (before consumption) and 4 weeks after consumption.
Key secondary outcomes 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.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 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.
Interventions/Control_2 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.
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

Not applicable
Gender Male and Female
Key inclusion criteria 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)
Key exclusion criteria 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
Target sample size 16

Research contact person
Name of lead principal investigator Kazuo YAMAMOTO
Organization ORTHOMEDICO Inc.
Division name CEO
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL 03-3818-0610
Email kazu@orthomedico.jp

Public contact
Name of contact person Naoko SUZUKI
Organization ORTHOMEDICO Inc.
Division name R&D Department
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 Nisshin Honey co.,ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Medical Corporation Seishinkai, Takara Clinic
Name of secondary funder(s)

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)

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 10 Day

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2018 Year 08 Month 06 Day
Anticipated trial start date
2018 Year 08 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 08 Month 10 Day
Last modified on
2018 Year 10 Month 12 Day


Link to view the page
URL(English) https://upload.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


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