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

Shoulder periarthritis (including a rotator cuff injury)

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

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

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

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 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

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name