UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040804 |
|---|---|
| Receipt number | R000046588 |
| Scientific Title | A confirmation study about relaxation of knee-joint discomfort by test-food intake |
| Date of disclosure of the study information | 2021/06/19 |
| Last modified on | 2021/06/24 18:53:22 |
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Basic information
Public title
A confirmation study about relaxation of knee-joint discomfort by test-food intake
Acronym
A confirmation study about relaxation of knee-joint discomfort by test-food intake
Scientific Title
A confirmation study about relaxation of knee-joint discomfort by test-food intake
Scientific Title:Acronym
A confirmation study about relaxation of knee-joint discomfort by test-food intake
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to evaluate whether test-food intakes can improve a knee-joint discomfort
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Visual Analog Scale (VAS)-
questionnaire scores about some kind of knee-joint discomfort.
2. Japanese Knee Osteoarthritis Measure (JKOM)-questionnaire scores.
Key secondary outcomes
1. EuroQOL 5 dimensions 5-level (EQ-5D-5L)-questionnaire scores about quality of life.
2. Activity of Daily Living (ADL)-test
3. Adverse events, and incidence rate of side effects
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
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Consumption of the test food to the subjects after breakfast, two drops a day for 12 weeks.
Interventions/Control_2
Consumption of the test food to the subjects after breakfast, two drops a day for 12 weeks.
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
| 40 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Male/female subjects ranging in age from 40 to 69.
(2) Subjects having chronic pain/discomfort on the knee since 6 months ago.
(3) Subjects who gave informed consent to participate in this trial after being provided with an explanation of the protocol detail.
Key exclusion criteria
Subjects with []
[1] some symptoms just like a muscular pain on a daily basis.
[2] some kind of medical treatment.
[3] diet/exercise therapies under the instruction of a medical doctor.
[4] therapies at an orthopedic or a pain-clinic.
[5] the grade II (and over) on a basis of KL (Kellgren-Lawrence) classification.
[6] previous history of some kind of knee-treatment (e.g., artificial knee replacement), or any necessity to treat their knee joint.
[7] a planning application of their knee-joint to some kind of drug-therapy.
[8] injections of hyaluronic acid to their knee-joint within two weeks before the agreement for the trial, or steroid to their's within three months before the agreement.
[9] previous history of diseases relating to the knee joint, such as a bone fracture, a sprain, etc.
[10] health-specific/functional/health foods that might affect the test results.
[11] the help of a stick on a daily basis.
[12] not less than 30 kg/m2 BMI.
[13] pregnancy, possible one, or lactation.
[14] previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs.
[15] excessive alcohol intake.
[16] extremely irregular life rhythms, midnight work or irregular shift work.
[17] previous medical history of drug and/or food allergy.
[18] the other clinical tests with some kind of medicines/foods, or taking part in those tests within four weeks after the current trial.
[19] donation of over 200 mL of their whole blood and/or blood components within a month to the current trial.
(20) Males who donated over 400 mL of their whole blood within the last three months to the current trial.
(21) Females who donated over 400 mL of their whole blood within the last four months to the current trial.
(22) Males who are going to be collected over 1200 mL within the last twelve months.
(23) Females who are going to be collected over 800 mL within the last twelve months.
(24) Others who have been determined as ineligible for participation.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Arata |
| Middle name | |
| Last name | Yamasaki |
Organization
Veritas Ltd.
Division name
President
Zip code
105-0014
Address
4F Ichiboshi Shibakoen Building, 2-29-14 Shiba, Minato-ku, Tokyo 105-0014, Japan
TEL
03-5297-3112
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Fujimoto |
Organization
CPCC Company Limited
Division name
Planning & Sales Department
Zip code
101-0047
Address
4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
TEL
03-5297-3112
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
IMEQRD CO., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Veritas 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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
Tel
03-5297-5548
IRB@cpcc.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 | 06 | Month | 19 | 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
| 2020 | Year | 05 | Month | 29 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 05 | 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 | 06 | Month | 17 | Day |
Last modified on
| 2021 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046588
