UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014652 |
|---|---|
| Receipt number | R000017046 |
| Scientific Title | A randomized controlled trial for improving QOL(quality-of-life) concerning knee joint in human |
| Date of disclosure of the study information | 2014/07/27 |
| Last modified on | 2014/12/10 20:57:07 |
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Basic information
Public title
A randomized controlled trial for improving QOL(quality-of-life) concerning knee joint in human
Acronym
A randomized controlled trial for improving QOL(quality-of-life) concerning knee joint in human
Scientific Title
A randomized controlled trial for improving QOL(quality-of-life) concerning knee joint in human
Scientific Title:Acronym
A randomized controlled trial for improving QOL(quality-of-life) concerning knee joint in human
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of the product containing S-adenosyl methionine (SAMe) yeast on knee joint
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Questionnaires(JKOM)
Key secondary outcomes
Physical examinations
Blood test
Urine test
Questionnaires(VAS, bodily sensation)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
SAMe yeast: 0mg/day
Duration: 12weeks
Interventions/Control_2
SAMe yeast: 500mg/day
Duration: 12weeks
Interventions/Control_3
SAMe yeast: 2500mg/day
Duration: 12weeks
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
| 50 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Males and females aged 50 to 74 years old
(2)Subjects who feel discomfort and/or pain on knee joint within the last 6 month, and the discomfort and/or pain are still continuing
Key exclusion criteria
(1)Patients being treated for rheumatoid arthritis
(2)Subjects who have a weak stomach, be suspected of gastrointestinal disease and/or have diarrhea routinely
(3)Subjects who have previous medical history and/or current medical history of serious diseases (e.g., heart, liver, kidney, pancreas, and/or digestive organ)
(4)Subjects who have hypertension (not less than level 3)
(5)Subjects who continuously use anti-inflammatory agent or muscle relaxant
(6)Subjects who continuously use pack and/or topical cream etc. on knee and/or leg region
(7)Subjects who continuously use medicines and/or Chinese herbal medicine, and can't stop using during this trial
(8)Subjects who use functional foods that have mitigation or treatment effect for joint pain (e.g., amino acid, protein, vitamin D, chondroitin, collagen, and/or glucosamine), and can't stop using during this trial
(9)Subjects who have previous medical history of drug and/or food allergy
(10)Subjects with excessive alcohol-drinking behaviors
(11)Subjects who contract or are under treatment for psychiatric disorder
(12)Subjects who have been enrolled in the other clinical trials within about last 1 month
(13)Subjects who are judged as unsuitable for the trial by the investigator or subinvestigator for other reasons
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuhisa SAKANO |
Organization
CPCC Company Limited
Division name
Clinical Research Planning Department
Zip code
Address
2F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan
TEL
03-5927-3112
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto ICHINOHE |
Organization
CPCC Company Limited
Division name
Plan sales department
Zip code
Address
2F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan
TEL
03-5927-3112
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Omnica 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
チヨダパラメディカルケアクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 27 | 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
| 2014 | Year | 07 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 28 | 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
| 2014 | Year | 07 | Month | 25 | Day |
Last modified on
| 2014 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017046
