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Recruitment status Completed
Unique ID issued by UMIN UMIN000014652
Receipt No. 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

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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)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email cpcc-contact@cpcc.co.jp

Sponsor
Institute CPCC Company Limited
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017046


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