UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045280 |
|---|---|
| Receipt number | R000051697 |
| Scientific Title | Observation of knee joints and subjective symptoms before and after taking supplements |
| Date of disclosure of the study information | 2021/08/30 |
| Last modified on | 2022/07/07 17:17:43 |
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Basic information
Public title
Observation of knee joints and subjective symptoms before and after taking supplements
Acronym
Observation of knee joints and subjective symptoms before and after taking supplements
Scientific Title
Observation of knee joints and subjective symptoms before and after taking supplements
Scientific Title:Acronym
Observation of knee joints and subjective symptoms before and after taking supplements
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Observation of knees and subjective symptoms after taking the supplement for 24 consecutive weeks
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of MRI imaging of the knee joint before and 24 weeks after ingestion
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take high doses of test food once daily for 24 consecutive weeks
Interventions/Control_2
Take medium dose of test food once daily for 24 consecutive weeks
Interventions/Control_3
Take placebo once daily for 24 consecutive weeks
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Subjects with the knee joint discomfort
2) Subjects with a BMI of less than 30kg/m^2
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
24
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
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguroku, Tokyo
Tel
03-6452-2712
saito.teruo876@eps.co.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
| 2021 | Year | 08 | Month | 30 | 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
| 2021 | Year | 07 | Month | 29 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 27 | Day |
Last modified on
| 2022 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051697
