UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023701 |
|---|---|
| Receipt number | R000027293 |
| Scientific Title | Research on the effectiveness of shoulder periarthritis collagen tripeptide that target (including the rotator cuff injury) |
| Date of disclosure of the study information | 2016/08/22 |
| Last modified on | 2016/08/20 11:44:25 |
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Basic information
Public title
Research on the effectiveness of shoulder periarthritis collagen tripeptide that target (including the rotator cuff injury)
Acronym
Research on the effectiveness of shoulder periarthritis collagen tripeptide that target (including the rotator cuff injury)
Scientific Title
Research on the effectiveness of shoulder periarthritis collagen tripeptide that target (including the rotator cuff injury)
Scientific Title:Acronym
Research on the effectiveness of shoulder periarthritis collagen tripeptide that target (including the rotator cuff injury)
Region
| Japan |
Condition
Condition
Shoulder periarthritis (including a rotator cuff injury)
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Administration of the CTP to the patient's shoulder periarthritis (including a rotator cuff injury), to clarify the impact of the improvement.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) shoulder joint disease assessment criteria (JOA1987)
2) direction of motion (flexion, extension, abduction, external rotation, internal rotation)
3) questionnaire (night pain, during exercise pain, the patient standing shoulder joint evaluation method Shoulder 36 (V1.3))
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
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
6 months
Interventions/Control_2
Once a day, the test meal one stick at dinner (can be any of the pre-meal, after a meal) orally to taken with a glass of water or lukewarm water cup.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. This study to understand, there is the ability to comply with it who
2. Prior to participation in the study, those who consent by the document can be obtained
3. It has been diagnosed with shoulder periarthritis (including a rotator cuff injury), who are feeling the pain in the affected area
Key exclusion criteria
1. Those who study doctor was ineligible as an object of the present study
2. A person who is suspected of inflammatory diseases such as shoulder calcific tendinitis and septic arthritis
3. Those of rheumatoid arthritis and fibromyalgia such as collagen disease, as well as persons with suspected
Four. Patients with cancer
Five. Persons with renal disease severe
6. A person who has a liver disorder of severe
7. Who during pregnancy and lactation
8. It is under ingestion other health supplements, functional foods, those who can not stop eating
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunichiro Imagawa |
Organization
Saiseikai Matsuyama hospital
Division name
Department of Rehabilitation
Zip code
Address
Matsuyama, Ehime Prefecture Shanxi-cho, 880-2
TEL
089-951-6111
chiken@matsuyama.saiseikai.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiharu Shimizu |
Organization
Saiseikai Matsuyama hospital
Division name
Clinical trial management office
Zip code
Address
Matsuyama, Ehime Prefecture Shanxi-cho, 880-2
TEL
089-951-6164
Homepage URL
chiken@matsuyama.saiseikai.or.jp
Sponsor or person
Institute
Saiseikai Matsuyama hospital
Institute
Department
Personal name
Funding Source
Organization
Saiseikai Matsuyama hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 08 | Month | 22 | 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
| 2016 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | 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
| 2016 | Year | 08 | Month | 20 | Day |
Last modified on
| 2016 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027293
