UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017133 |
|---|---|
| Receipt number | 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 09:10:52 |
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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
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
info@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019810
