UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039388 |
|---|---|
| Receipt number | R000044911 |
| Scientific Title | The observation of knee joint before and after supplement intake |
| Date of disclosure of the study information | 2020/02/04 |
| Last modified on | 2020/02/21 19:04:11 |
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Basic information
Public title
The observation of knee joint before and after supplement intake
Acronym
The observation of knee joint before and after supplement intake
Scientific Title
The observation of knee joint before and after supplement intake
Scientific Title:Acronym
The observation of knee joint before and after supplement intake
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The observation of the knee after continuous intake of supplement for 48 weeks
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
None
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of the supplement once a day for 48 consecutive weeks
Interventions/Control_2
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
| 60 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy woman with the knee joint discomfort
Key exclusion criteria
1. Subjects with severe pain in joints other than the knee joint
2. Subjects who have a current or previous history of joint disease or serious disease that affects efficacy evaluation
3. Subjects who regularly use medicines and health foods that affect efficacy evaluation
4. Subjects who are judged inappropriate by the investigator
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Young-Soo |
| Middle name | |
| Last name | Kim |
Organization
KOBAYASHI Pharmaceutical Co.,Ltd
Division name
Central R&D Laboratory
Zip code
567-0057
Address
1-30-3, Toyokawa, Ibaraki-city, Osaka
TEL
080-3465-0719
y.kim@kobayashi.co.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Makino |
Organization
KOBAYASHI Pharmaceutical Co.,Ltd
Division name
Central R&D Laboratory
Zip code
567-0057
Address
1-30-3, Toyokawa, Ibaraki-city, Osaka
TEL
080-3465-2263
Homepage URL
t.makino@kobayashi.co.jp
Sponsor or person
Institute
KOBAYASHI Pharmaceutical Co.,Ltd
Institute
Department
Personal name
Funding Source
Organization
KOBAYASHI Pharmaceutical 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
Aisei Hospital Ueno Clinic Reserch Ethics Committee
Address
2-18-6 Higashiueno, Taito-ku, Tokyo
Tel
03-6455-0880
t.saito@ttc-smo.jp
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
| 2020 | Year | 02 | Month | 04 | 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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 12 | Month | 26 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 04 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 04 | Day |
Last modified on
| 2020 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044911
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
