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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000039388
Receipt No. 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

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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
Email 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
Email t.makino@kobayashi.co.jp

Sponsor
Institute KOBAYASHI Pharmaceutical Co.,Ltd
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044911

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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