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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027732
Receipt No. R000031763
Scientific Title A clinical study for evaluating the safety of excessive intake of salmon nasal cartilage extract including proteoglycan
Date of disclosure of the study information 2017/06/13
Last modified on 2017/06/12

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Basic information
Public title A clinical study for evaluating the safety of excessive intake of salmon nasal cartilage extract including proteoglycan
Acronym A clinical study for evaluating the safety of excessive intake of salmon nasal cartilage extract
Scientific Title A clinical study for evaluating the safety of excessive intake of salmon nasal cartilage extract including proteoglycan
Scientific Title:Acronym A clinical study for evaluating the safety of excessive intake of salmon nasal cartilage extract
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety of excessive intake of salmon nasal cartilage extract for 4 weeks in healthy adults.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Hematologic test
Biochemistry test
Urinalysis
Medical interview
Adverse event
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 Prevention
Type of intervention
Food
Interventions/Control_1 Consumption of salmon nasal cartilage extract,
5 fold quantity of recommended daily intake, for 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
65 years-old >=
Gender Male and Female
Key inclusion criteria 1) Healthy men and women.
2) Subjects giving written informed consent based on Declaration of Helsinki.
3) Subjects who can intake test food sample every day during test period.
4) Subjects who can attend to every examinations.
Key exclusion criteria 1) Subjects who take drugs or supplements
2) Subjects undergoing treatment for some serious disorders
3) Subjects who make a blood donation within the last month before and during the test
4) Women who are pregnant or breast-feeding
5) Subjects who have allergies to salmon, shrimp or crab
6) Subjects whose participation is deemed inappropriate by pilot questionnaire, clinical test values or physical exam values
7) Subjects who cannot follow a guideline of test
8) Subjects undergoing hormone replacement therapy
9) Subjects whose participation is deemed inappropriate by a test director
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazue Takayama
Organization Ichimaru Pharcos Co., Ltd.
Division name Product Development
Zip code
Address 318-1 Asagi, Motosu-Shi, Gifu 501-0475 Japan
TEL 058-320-1036
Email takayama-kazue@ichimaru.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazunori Enya
Organization Ichimaru Pharcos Co., Ltd.
Division name Product Development
Zip code
Address 318-1 Asagi, Motosu-Shi, Gifu 501-0475 Japan
TEL 058-320-1037
Homepage URL
Email enya-kazunori@ichimaru.co.jp

Sponsor
Institute Ichimaru Pharcos Co., Ltd.
Institute
Department

Funding Source
Organization Ichimaru Pharcos Co., Ltd.
Organization
Division
Category of Funding Organization Self funding
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 独立行政法人地域医療機能推進機構 可児とうのう病院 健康管理センター

Other administrative information
Date of disclosure of the study information
2017 Year 06 Month 13 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 07 Month 06 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 13 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
2017 Year 06 Month 12 Day
Last modified on
2017 Year 06 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031763

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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