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Recruitment status Completed
Unique ID issued by UMIN UMIN000011196
Receipt No. R000013118
Scientific Title Effect of Lentinula edodes (Shiitake mushroom) for allergic rhinitis and atopic dermatitis
Date of disclosure of the study information 2013/07/16
Last modified on 2016/01/18

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Basic information
Public title Effect of Lentinula edodes (Shiitake mushroom) for allergic rhinitis and atopic dermatitis
Acronym Effect of Lentinula edodes (Shiitake mushroom) for allergic rhinitis and atopic dermatitis
Scientific Title Effect of Lentinula edodes (Shiitake mushroom) for allergic rhinitis and atopic dermatitis
Scientific Title:Acronym Effect of Lentinula edodes (Shiitake mushroom) for allergic rhinitis and atopic dermatitis
Region
Japan

Condition
Condition allergic rhinitis, atopic dermatitis
Classification by specialty
Dermatology Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Examination of the effect of Lentinula edodes (Shiitake mushroom) for allergic rhinitis and atopic dermatitis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Assesment of these diseases before and after (4 weeks after) as below.
allergic rhinitis: medical examination at the department of otorhinolaryngology with a disease questionnaire
atopic dermatitis: medical examination at the department of dermatology with a disease questionnaire
Key secondary outcomes serum biomarkers

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

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

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Groups
1; no administration,
Duration: 4 weeks
Dose: Non
Times: 1 time/day
Interventions/Control_2 Groups
2; shiitake chips A,
Duration: 4 weeks
Dose: Chips 3 gram
Times: 1 time/day
Interventions/Control_3 Groups
3; shiitake chips B
Duration: 4 weeks
Dose: Chips 3 gram
Times: 1 time/day
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria allergic rhinitis or atopic dermatitis diagnosed by each specialists
Key exclusion criteria Patients judged inappropriate for this study by the physicians
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaru Yoshida
Organization Kobe University Graduate School of Medicine
Division name Division of Metabolomics Research
Zip code
Address 7-5-1, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017, JAPAN
TEL +81-78-382-6305
Email myoshida@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaru Yoshida
Organization Kobe University Graduate School of Medicine
Division name Division of Metabolomics Research
Zip code
Address 7-5-1, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017, JAPAN
TEL +81-78-382-6305
Homepage URL http://www.med.kobe-u.ac.jp/metabo/index.html
Email myoshida@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Graduate School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization the Ministry of Agriculture, Forestry and Fisheries
Organization
Division
Category of Funding Organization
Nationality of Funding Organization JAPAN

Other related organizations
Co-sponsor none
Name of secondary funder(s) none

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 神戸大学病院

Other administrative information
Date of disclosure of the study information
2013 Year 07 Month 16 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
2013 Year 02 Month 06 Day
Date of IRB
Anticipated trial start date
2013 Year 03 Month 01 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
2016 Year 03 Month 31 Day
Date trial data considered complete
2016 Year 03 Month 31 Day
Date analysis concluded
2016 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 07 Month 16 Day
Last modified on
2016 Year 01 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013118


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