UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027699 |
|---|---|
| Receipt number | R000031730 |
| Scientific Title | The efficacy evaluation of the knee subjective symptoms and motor function by collagen containing drink |
| Date of disclosure of the study information | 2017/06/09 |
| Last modified on | 2018/06/11 10:45:45 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The efficacy evaluation of the knee subjective symptoms and motor function by collagen containing drink
Acronym
The efficacy evaluation of the knee subjective symptoms and motor function by collagen containing drink
Scientific Title
The efficacy evaluation of the knee subjective symptoms and motor function by collagen containing drink
Scientific Title:Acronym
The efficacy evaluation of the knee subjective symptoms and motor function by collagen containing drink
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of collagen containing drink on the knee subjective symptoms and motor function for 12 weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
locomotive syndrome risk test, JKOM before and 6, 12 weeks after the intervention with the test drink
Key secondary outcomes
JOA, levels of change in knee joint stiffness, VAS, handgrip before and 6, 12 weeks after the intervention with the test drink
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Collagen containing drink are ingested for 12 consecutive weeks
Interventions/Control_2
Collagen free drink are ingested for 12 consecutive 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
| 40 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Males and females at the ages of 40 to 74
(2)Subjects who are judged as stage 1 in locomotive syndrome risk test
(3)Subjects who confirmed pain of knee joint by JKOM and VAS
(4)Subjects who are classified into 0-I grade on the basis of the Kellgren-Lawrence classification. (Subjects who undiagnosed with Knee Osteoarthritis by physician)
Key exclusion criteria
(1)Subjects who exceeded the value of knee pain on JKOM, question-I : the degree of pain, more than the sum VAS value of other joint pain (e.g., ankle, elbow, finger, shoulder, back and hip)
(2)Subjects who are confirmed 30-points by JOA score, the degree of knee pain and walk ability
(3)Subjects who are suspected gouty attack with hyperuricemia
(4)Subjects who have positive rheumatoid factors on the screening test or may have rheumatic pain
(5)Subjects who have performed arthroplasty or need it
(6)Subjects who regularly take health food containing bone, joint, muscle wellness from three month before the screening test to the end of the study
(7)Subjects who regularly take medicine
(8)Subjects who have been performed intra-articular hyaluronic acid or steroid drug injection within a year before the screening test
(9)Subjects who get an intense exercise to make excessive load on the joints
(10)Subjects who have a history of the disorder related to bone and joint such as fracture and sprain within a year before the screening test
(11)Subjects who regularly use a stick or supporter
(12)Subjects who routinely exert an influence on the efficacy evaluation
(13)Subjects who get a diagnosis of malignancy, are under treatment for hypertension, cardiac disease, renal disease and thyroid dysfunction, and have a history of serious disorder such as hepatic disease
(14)Subjects who consume an excess amounts of alcohol
(15)Subjects who have possibility of allergy symptoms onset by the test supplement
(16)Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(17)Subjects who have participated in other clinical study within a month before the screening test or who intend to participate in study period
(18)Subjects who intend to become pregnant or lactating
(19)Subjects who are judged as unsuitable for this study by physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sadao Mori |
Organization
Morinaga & Co.,Ltd
Division name
Health and Wellness Headquarters
Zip code
Address
2-1-1, Shimodueyoshi, Tsurumi-ku, Yokohama
TEL
070-3864-8266
s-mori-ab@morinaga.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriko Watanabe |
Organization
TTC Co.,Ltd
Division name
Clinical Research Planning Department
Zip code
Address
Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL
03-5459-5329
Homepage URL
n.watanabe@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co.,Ltd
Institute
Department
Personal name
Funding Source
Organization
Morinaga & 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
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
| 2017 | Year | 06 | Month | 09 | 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
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 12 | 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
| 2017 | Year | 06 | Month | 09 | Day |
Last modified on
| 2018 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031730
