UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016220
Receipt number 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 18:33:29

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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 or person

Institute

ORTHOMEDICO, Inc.

Institute

Department

Personal name



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

Value
https://center6.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