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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017133
Receipt No. R000019810
Scientific Title Assessment of Safety of a Supplement Containing Mushroom Chitosan in Case of Excess Ingestion
Date of disclosure of the study information 2015/04/14
Last modified on 2015/04/14

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Basic information
Public title Assessment of Safety of a Supplement Containing Mushroom Chitosan in Case of Excess Ingestion
Acronym Safety of a Supplement Containing Mushroom Chitosan
Scientific Title Assessment of Safety of a Supplement Containing Mushroom Chitosan in Case of Excess Ingestion
Scientific Title:Acronym Safety of a Supplement Containing Mushroom Chitosan
Region
Japan

Condition
Condition Safty varification of a supplement containing mushroom chitosan
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to evaluate safty of a supplement containing mushroom chitosan in case of excess ingestion.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Body structure
Blood pressure
Pulsation
Blood biochemistry test
Urine analysis
Doctor's questions
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Oral ingestion of the test product (4 weeks)
Interventions/Control_2
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
59 years-old >
Gender Male and Female
Key inclusion criteria [1]Japanese males and females aged 20-59 years
[2]Individuals whose BMI is less than 25 kg/m^2 (12 subjects)
[3]Individuals whose BMI is over 25 kg/m^2 (12subjects)
Key exclusion criteria [1]Individuals using or will use medical products
[2]Individuals who had a habit to ingest health-promoting foods
[3]Individuals who are or are posslibly, or are lactating
[4]Individuals who excessively take alcohol
[5]Individuals who have symptoms of allergy to the test product
[6]Individuals who participate in other clinical studies
[7]Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease
[8]Individuals with serious anemia
[9]Individuals who had been administrated contrast material (ex. barium) in the past 2 months or will be administrated during the test period
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akimasa Matsuyama
Organization Shirogane EXE Clinic
Division name Internal Medicine
Zip code
Address 2F Charming Square Shirogane, 6-16-6 Shirogane Minato-ku Tokyo 108-0072, JAPAN
TEL 03-5939-0701
Email info@tes-h.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name TES Holdings Co., Ltd.
Organization TES Holdings Co., Ltd.
Division name Department of Clinical Trial
Zip code
Address 6F University of Tokyo Entrepreneur Plaza, 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN
TEL 03-6801-8480
Homepage URL
Email info@tes-h.co.jp

Sponsor
Institute TES Holdings Co., Ltd.
Institute
Department

Funding Source
Organization RICOM Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 04 Month 14 Day

Related information
URL releasing protocol
Publication of results Published

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
2008 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 06 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 04 Month 14 Day
Last modified on
2015 Year 04 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019810

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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