UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015911 |
|---|---|
| Receipt number | R000018519 |
| Scientific Title | The test of the improvement effect for knee joint of the S-adenosylmethionine-containing food |
| Date of disclosure of the study information | 2014/12/10 |
| Last modified on | 2015/02/20 10:05:24 |
* 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 test of the improvement effect for knee joint of the S-adenosylmethionine-containing food
Acronym
The test of the improvement effect for knee joint of the S-adenosylmethionine-containing food
Scientific Title
The test of the improvement effect for knee joint of the S-adenosylmethionine-containing food
Scientific Title:Acronym
The test of the improvement effect for knee joint of the S-adenosylmethionine-containing food
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
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Questionnaires(VAS, bodily sensation)
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
SAMe yeast(4weeks)
Interventions/Control_2
Placebo (4weeks)
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
| 35 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Healthy males and females aged 35 to 59 years old
(2)Subjects who feel discomfort on knee joint since over 3 months ago, and the discomfort are still continuing
Key exclusion criteria
(1)Patients under medical treatment
(2)Subjects who have previous medical history of drug and/or food allergy
(3)Subjects who have hypertension (not less than level 3)
(4)Subjects who have previous medical history of the serious diseases (heart, liver, kidney, blood, digestive system,metabolism system)
(5)Patients being treated for rheumatoid arthritis
(6)Subjects who have disturbance of motility
(7)Subjects who use SAMe-containing-foods and/or 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
(8)Subjects who take medicines and plan to take new health foods
(9)Subjects who hope for pregnancy in the test duration, pregnant woman, lactating woman
(10)Subjects who have been enrolled in the other clinical trials within about last 1 month
(11)Subjects whose declaration of application is incorrect clearly
(12)Subjects who are judged as unsuitable for the trial by the investigator or subinvestigator for other reasons
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Haruo MARUYAMA |
Organization
Universal Clinical Systems Co., Ltd.
Division name
Clinical Research Planning Department
Zip code
Address
4F Komori Build. 2-5-3 Kyobashi Chuo-ku, Tokyo Japan
TEL
03-3816-3121
info@uc-system.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriko YAMANAKA |
Organization
Omnica Co.,Ltd
Division name
Research team
Zip code
Address
TN Koishikawa BLDG. 5F, 1-15-17 Koishikawa, Bunkyo-ku, Tokyo, JAPAN
TEL
03-5840-9811
Homepage URL
yamanaka@omnica.co.jp
Sponsor or person
Institute
Universal Clinical Systems Co., Ltd.
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 10 | 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 | 12 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 11 | 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 | 12 | Month | 10 | Day |
Last modified on
| 2015 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018519
