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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023701
Receipt No. 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

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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
Email 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
Email chiken@matsuyama.saiseikai.or.jp

Sponsor
Institute Saiseikai Matsuyama hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027293

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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