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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Not applicable | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 34 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |