UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research on the effectiveness of shoulder periarthritis collagen tripeptide that target (including the rotator cuff injury)
Title of the study (Brief title)	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	Shunichiro Imagawa
Organization	Saiseikai Matsuyama hospital
Division name	Department of Rehabilitation
Address	Matsuyama, Ehime Prefecture Shanxi-cho, 880-2
TEL	089-951-6111
Email	chiken@matsuyama.saiseikai.or.jp

Public contact
Name of contact person	Yoshiharu Shimizu
Organization	Saiseikai Matsuyama hospital
Division name	Clinical trial management office
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 03 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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