UMIN-CTR Clinical Trial

Basic information
Public title	Biological reaction by chondroitin sulfate in healthy subjects: randomized, double-blind, placebo-controlled trial
Acronym	Biological reaction by chondroitin sulfate
Scientific Title	Biological reaction by chondroitin sulfate in healthy subjects: randomized, double-blind, placebo-controlled trial
Scientific Title:Acronym	Biological reaction by chondroitin sulfate
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate biological reaction by oral chondroitin sulfate
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Subjective evaluation of fatigue and pain, evaluation of cardiopulmonary function, evaluation of maximal voluntary contraction
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	Medicine
Interventions/Control_1	Active treatment for 4 weeks
Interventions/Control_2	Placebo treatment 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	35 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Subjects aged 35 to 75 years on the day of signing the informed consent (2) Healthy subjects who do not have severe disease in cardiovascular system (3) Subjects who have received written informed consent
Key exclusion criteria	(1) Subjects who have history of severe disease (2) Subjects who are treated with medicine, intervention of exercise or diet by doctor (3) Subjects who are judged as inappropriate by investigator and doctor
Target sample size	34

Research contact person
Name of lead principal investigator	1st name Norio Middle name Last name Hotta
Organization	Chubu University
Division name	Department of Lifelong Sports for Health College of Life and Health Sciences
Zip code	487-8501
Address	1200 Matsumoto-cho, Kasugai-shi, Aichi
TEL	0568-51-9667
Email	horinori@isc.chubu.ac.jp

Public contact
Name of contact person	1st name Norio Middle name Last name Hotta
Organization	Chubu University
Division name	Department of Lifelong Sports for Health College of Life and Health Sciences
Zip code	487-8501
Address	1200 Matsumoto-cho, Kasugai-shi, Aichi
TEL	0568-51-9667
Homepage URL
Email	horinori@isc.chubu.ac.jp

Sponsor
Institute	Chubu University
Institute
Department

Funding Source
Organization	ZERIA Pharmaceutical Co., Ltd.
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	Ethics Committee of Chubu University
Address	1200 Matsumoto-cho, Kasugai-shi, Aichi
Tel	0568-51-1111
Email	horinori@isc.chubu.ac.jp

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	2020 Year 04 Month 30 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	2018 Year 01 Month 28 Day
Date of IRB	2013 Year 10 Month 21 Day
Anticipated trial start date	2018 Year 01 Month 31 Day
Last follow-up date	2018 Year 10 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 03 Month 26 Day
Last modified on	2020 Year 10 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036417

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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