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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035251
Receipt No. R000040113
Scientific Title Examination of the Effects and Safety of a Test Food Ingestion on Knee Pain and Motility Function: A Placebo-Controlled, Randomized, Double-Blind, Parallel-Group Study
Date of disclosure of the study information 2018/12/14
Last modified on 2019/06/14

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Basic information
Public title Examination of the Effects and Safety of a Test Food Ingestion on Knee Pain and Motility Function: A Placebo-Controlled, Randomized, Double-Blind, Parallel-Group Study
Acronym Examination of the Effects and Safety of a Test Food Ingestion on Knee Pain and Motility Function
Scientific Title Examination of the Effects and Safety of a Test Food Ingestion on Knee Pain and Motility Function: A Placebo-Controlled, Randomized, Double-Blind, Parallel-Group Study
Scientific Title:Acronym Examination of the Effects and Safety of a Test Food Ingestion on Knee Pain and Motility Function
Region
Japan

Condition
Condition N/A(healthy adults)
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to examine the effects and safety of a test food ingestion on knee pain and motility function with placebo-controlled, randomized, double-blind, and parallel-group method.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes [1]Japanese Knee Osteoarthritis Measure (JKOM; Screening, Week 0, Week 4, Week 12).
Key secondary outcomes *Secondary outcomes
[1]The Japan Orthopaedic Association Score (JOA Score; Screening, Week 0, Week 4, Week 12).
[2]The 25-question geriatric locomotive function scale (Screening, Week 0, Week 4, Week 12).
[3]Stand-up test (Screening, Week 0, Week 4, Week 12).
[4]2-step test (Screening, Week 0, Week 4, Week 12).
[5]Timed up & go test (Screening, Week 12).

*Safety
[1]Blood pressure, pulsation (Screening, Week 0, Week 4, Week 12).
[2]Weight, body fat percentage, BMI (Screening, Week 0, Week 4, Week 12).
[3]Hematologic test (Screening, Week 0, Week 12).
[4]Blood biochemical test (Screening, Week 0, Week 12).
[5]Urine analysis (Screening, Week 0, Week 12).
[6]Doctor's questions (Screening, Week 0, Week 4, Week 12).
[7]Subject's diary (From the first day of ingestion of a test material to the last day of the test).

*Other index
[1]Evaluation of knee with Kellgren-Lawrence grading system (Screening).

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 Oral ingestion of a test food (one time in a day; 12 weeks).
Interventions/Control_2 Oral ingestion of a placebo food (one time in a day; 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
75 years-old >=
Gender Male and Female
Key inclusion criteria [1]Healthy Japanese males and females aged 40-75 years.
[2]Individuals who are healthy and have no chronic physical disease.
[3]Individuals who are aware of knee pain.
[4]Individuals whose written informed consent has been obtained.
[5]Individuals who can have an examination on a designated check day.
[6]Individuals judged appropriate for the study by the principal.
Key exclusion criteria [1]Individuals using medical products.
[2]Individuals receiving outpatient care (except for bonesetters, chiropractors, massagers) for knee and/or low back pain.
[3]Individuals who are a patient or have a history of rheumatic disease.
[4]Individuals whose grade of Kellgren-Lawrence grading system is over Grade II.
[5]Individuals with history of palliative therapy (hyaluronic acid, steroid injection, etc.) or surgical therapy (arthroscopic osteotomy, artificial joint, bolt fixation surgery, etc.)on knees and/or waist.
[6]Individuals under treatment or with history of mental disorders, sleep disorders, hypertension, diabetes, lipid metabolism abnormality, or other serious disorders.
[7]Individuals who are a patient or have a history of receiving medical drug treatment for the past 1 month (except for temporary relief medication for headache, menstrual pain, common cold).
[8]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease.
[9]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease.
[10]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
[11]Individuals with serious anemia.
[12]Individuals who are sensitive to test product or other foods, and medical products.
[13]Individuals having a habit to intake a food containing the component of the test food.
[14]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day).
[15]Individuals who may significantly change exercise habit or lifestyle during the study period.
[16]Individuals who are or are possibly, or are lactating.
[17]Individuals who participated in other clinical studies in the past 3 months.
[18]Individual with potential conflict of interests.
[19]Individuals judged inappropriate for the study by the principal.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name Yasuo
Middle name
Last name Kobuna
Organization Medical Cooperation Koyukai Kobuna Orthopedic Surgery
Division name Head
Zip code 371-0813
Address 311-2 Gokanmachi Maebashi-shi Gunma 371-0813, JAPAN
TEL +81-27-261-7600
Email info@tes-h.co.jp

Public contact
Name of contact person
1st name Ryoma
Middle name
Last name Shimizu
Organization TES Holding Co., Ltd.
Division name Administrative Department of Clinical Trials
Zip code 110-0015
Address 6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL +81-3-6801-8480
Homepage URL
Email r.shimizu@tes-h.co.jp

Sponsor
Institute TES Holding 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 Medical Cooperation Koyukai Kobuna Orthopedic Surgery Ethical Committee
Address 311-2 Gokanmachi Maebashi-shi Gunma 371-0813, JAPAN
Tel +81-27-261-7600
Email jimukyoku@tes-h.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
2018 Year 12 Month 14 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
2018 Year 11 Month 12 Day
Date of IRB
2018 Year 11 Month 15 Day
Anticipated trial start date
2018 Year 12 Month 14 Day
Last follow-up date
2019 Year 03 Month 16 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 12 Month 14 Day
Last modified on
2019 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040113

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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