UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031899 |
|---|---|
| Receipt number | 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 18:08:45 |
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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
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
horinori@isc.chubu.ac.jp
Sponsor or person
Institute
Chubu University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036417
