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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000026388
Receipt No. R000030300
Scientific Title Safety evaluation of execessive consumption of proteoglycan complex 80 from salmon nasal cartilage - a randomized, double blind, placebo-controlled study -
Date of disclosure of the study information 2017/06/01
Last modified on 2017/03/03

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Basic information
Public title Safety evaluation of execessive consumption of proteoglycan complex 80 from salmon nasal cartilage - a randomized, double blind, placebo-controlled study -
Acronym Safety evaluation of execessive consumption of proteoglycan complex 80 from salmon nasal cartilage
Scientific Title Safety evaluation of execessive consumption of proteoglycan complex 80 from salmon nasal cartilage - a randomized, double blind, placebo-controlled study -
Scientific Title:Acronym Safety evaluation of execessive consumption of proteoglycan complex 80 from salmon nasal cartilage
Region
Japan

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

Objectives
Narrative objectives1 To investigate the safety of excessive consumption of proteoglycan complex 80 for 4 weeks
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Bloodchemistry, hematology and urine analysis at 2-week, 4-week consumption and 2-week after consumption period
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Ingestion of supplement containing proteoglycan complex 80 for 4 weeks
Interventions/Control_2 Ingestion of placebo without proteoglycan complex 80 for 4 weeks
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 male and female age 20 to 65 inclusive at the time of informed consent, BMI >30 inclusive.
2.Subjects who received an enough explanation of the test objectives and detail, who have consent ability, who are willing to participate with well understandings and who have signed the informed consent document.
Key exclusion criteria 1.Subjects who have been continuously treated by medicine.
2.Subjects who have a history of renal, hepatic, cardiac, respiratory, endocrine, or other metabolic disease or who have been treated for those diseases.
3.Subjects who have been regularly used medicine (Including antiflatulent and laxative)
4.Subjects who cannot stop taking supplement/health food (Including Special Health Food, Foods with "Function Claims")
5.Subjects who declared having an allergy for component of test tablet
6.Subjects who have a past surgical history or a history of digestive disease which affects digestion.
7.Subjects who are pregnant, willing to be pregnant or breast feeding.
8.Subjects with a history of drug dependence or alcohol dependence or past history of drug dependence or alcohol dependence
9.Subjects who made a blood component donation or whole blood donation more than 200mL within 4 weeks before the test starts
10.Subjects who have shift work or night shift work.
11.Subjects who have been participated in any other food or medicine intake clinical trial, cosmetic and medicine application trial or participated in any other clinical trial within 1 month after consent obtain, or who is willing to participate.
12.Any who is judged as unsuitable to participate in this clinical trial through by principal investigator or sub-investigator.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuo Kobuna
Organization Kobuna orthopedic surgery
Division name Medical office
Zip code
Address 311-2, Gokanmachi, Maebashi, Gunma
TEL 027-261-7600
Email info@kobunaseikei.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshika Komori
Organization KSO Corporation
Division name Sales department
Zip code
Address 1-9-7 Shibaura, Minato-ku, Tokyo
TEL 03-3452-7733
Homepage URL
Email yoshi@kso.co.jp

Sponsor
Institute KSO Corporation
Institute
Department

Funding Source
Organization Nihon Pharmaceutical
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
2017 Year 06 Month 01 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 Preinitiation
Date of protocol fixation
2017 Year 02 Month 14 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 06 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 03 Month 03 Day
Last modified on
2017 Year 03 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030300

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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