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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016220
Receipt No. R000018822
Scientific Title A clinical trial to evaluate the effect of improving allergy-like symptoms: A randomized controlled trial.
Date of disclosure of the study information 2015/01/15
Last modified on 2017/01/30

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Basic information
Public title A clinical trial to evaluate the effect of improving allergy-like symptoms: A randomized controlled trial.
Acronym A clinical trial to evaluate the effect of improving allergy-like symptoms
Scientific Title A clinical trial to evaluate the effect of improving allergy-like symptoms: A randomized controlled trial.
Scientific Title:Acronym A clinical trial to evaluate the effect of improving allergy-like symptoms
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This trial aims to evaluate the effect of ingestion of the test foods on allergy-like symptoms such as rhinitis to subjects feeling these symptoms.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes [JRQLQ]
nasal symptom
ophthalmic symptom
QOL question
Key secondary outcomes

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 No need to know

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Duration: 8 weeks
Test material: Shiitake mycelium extract powder
Usage and Dose: 4 capsules/day (after breakfast and after dinner, each 2 capsules with water or plain hot water.)
Interventions/Control_2 Duration: 8 weeks
Test material: Shiitake mycelium extract powder and Bifidobacterium BR108
Usage and Dose: 4 capsules/day (after breakfast and after dinner, each 2 capsules with water or plain hot water.)
Interventions/Control_3 Duration: 8 weeks
Test material: Placebo
Usage and Dose: 4 capsules/day (after breakfast and after dinner, each 2 capsules with water or plain hot water.)
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 Healthy adults, who suffer from allergy-like symptoms
Key exclusion criteria a.Persons who have previous medical history of malignant tumor or heart failure or myocardial infarction

b.Patients being treated for at least one of following diseases atrial fibrillation, cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension and other chronic disease

c.Persons who take medicines, herbal medicines, supplements related to test food.

d.Persons who take foods/drinks expected to be related with gut health, such as Food for Specified Health Uses (FOSHU), yogurt and, lactic fermenting beverage

e.Persons who are allergic to medicines, or products related to the test material of this trial

f. Persons who have been judged as pollinosis by doctors

g.Pregnant women, lactating women, or women who want to get pregnant during the trial period

h.Persons who have been enrolled in the other clinical trials within last 3 months before the agreement for the participation to this trial

i.Persons who are judged not suitable to participate in this trial by physician
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo YAMAMOTO
Organization ORTHOMEDICO, Inc.
Division name R&D Department
Zip code
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL 03-3818-0610
Email kazu@orthomedico.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoko SUZUKI
Organization ORTHOMEDICO, Inc.
Division name R&D Department
Zip code
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL 03-3818-0610
Homepage URL
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO, Inc.
Institute
Department

Funding Source
Organization Amino Up Chemical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Seishin-kai Medical Association Inc, Takara Medical Clinic.
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2015 Year 01 Month 15 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 Completed
Date of protocol fixation
2015 Year 01 Month 14 Day
Date of IRB
Anticipated trial start date
2015 Year 01 Month 16 Day
Last follow-up date
2015 Year 05 Month 01 Day
Date of closure to data entry
2015 Year 05 Month 15 Day
Date trial data considered complete
2015 Year 05 Month 20 Day
Date analysis concluded
2015 Year 05 Month 29 Day

Other
Other related information

Management information
Registered date
2015 Year 01 Month 15 Day
Last modified on
2017 Year 01 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018822

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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