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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031899
Receipt No. R000036417
Scientific Title Biological reaction by chondroitin sulfate in healthy subjects: randomized, double-blind, placebo-controlled trial
Date of disclosure of the study information 2020/04/30
Last modified on 2020/10/01

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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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