UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031558 |
|---|---|
| Receipt number | R000036033 |
| Scientific Title | Effects of nutrient in Japanese subjects with knee pain: a randomized, double-blind, placebo-controlled, parallel pilot study. |
| Date of disclosure of the study information | 2018/03/02 |
| Last modified on | 2018/05/08 11:13:02 |
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Basic information
Public title
Effects of nutrient in Japanese subjects with knee pain: a randomized, double-blind, placebo-controlled, parallel pilot study.
Acronym
Effects of nutrient in Japanese subjects with knee pain
Scientific Title
Effects of nutrient in Japanese subjects with knee pain: a randomized, double-blind, placebo-controlled, parallel pilot study.
Scientific Title:Acronym
Effects of nutrient in Japanese subjects with knee pain
Region
| Japan |
Condition
Condition
Knee pain
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of nutrient intake on knee pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
VAS score of knee pain, JKOM score
Key secondary outcomes
Blood metabolite concentrations, Blood enzyme activities
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Active supplement (continuous intake for 12W)
Interventions/Control_2
Placebo supplement (continuous intake for 12W)
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
| 45 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
-Subjects who have high scores of JKOM(II-V)
Key exclusion criteria
-Subjects who have therapeutic history for at least 2 year for knee joint pain
-Subjects who suffer from articular rheumatism
-Subjects who suffer from liver or kidney disease
-Subjects who have therapeutic history for serious liver, kidney or heart disease
-Subjects who have medication for knee joint pain (anodyne, anti-inflammation)
-Subjects who have therapeutic history for at least 1 year for serious locomotor system (for example, a fracture, a tendon rapture, a pulled muscle)
-Subjects who take excess alcohol
-Subjects who take supplement including chondroitin sulfate or glucosamine for knee joint pain in daily
-Subjects who are not eligible due to physician's judgment
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shingo Kakuo |
Organization
Kao Corporation
Division name
Biological Science Laboratory
Zip code
Address
2606 Akabane, Ichikai-Machi, Haga-Gun, Tochigi
TEL
+81-285-68-7440
kakuo.shingo@kao.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shingo Kakuo |
Organization
Kao Corporation
Division name
Biological Science Laboratory
Zip code
Address
2606 Akabane, Ichikai-Machi, Haga-Gun, Tochigi
TEL
+81-285-68-7440
Homepage URL
kakuo.shingo@kao.com
Sponsor or person
Institute
SOUKEN Laboratories
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
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
芝パレスクリニック (Shiba Palace Clinic)（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1007/s40520-018-0953-6
Number of participants that the trial has enrolled
Results
-Continuous intake of active nutrient significantly lowered VAS score of knee pain.
-Continuous intake of active nutrient significantly relieved knee pain and stiffness.
Aging Clinical and Experimental Research
(https://doi.org/10.1007/s40520-018-0953-6)
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
| 2011 | Year | 09 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2012 | Year | 05 | Month | 22 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 02 | Day |
Last modified on
| 2018 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036033
| 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 |
