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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033446
Receipt No. R000038134
Scientific Title Effects of consumption of the test food in healthy Japanese with discomfort in the knee joint: a randomized, double-blind, placebo-controlled, parallel-group trial
Date of disclosure of the study information 2018/07/19
Last modified on 2018/12/25

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Basic information
Public title Effects of consumption of the test food in healthy Japanese with discomfort in the knee joint: a randomized, double-blind, placebo-controlled, parallel-group trial
Acronym Effects of consumption of the test food in healthy Japanese with discomfort in the knee joint
Scientific Title Effects of consumption of the test food in healthy Japanese with discomfort in the knee joint: a randomized, double-blind, placebo-controlled, parallel-group trial
Scientific Title:Acronym Effects of consumption of the test food in healthy Japanese with discomfort in the knee joint
Region
Japan

Condition
Condition Healthy Japanese subjects
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the effects on discomfort in the knee joint with the test food for 12 weeks in healthy Japanese adult subjects with discomfort in the knee joint
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The total score of Japanese Knee Osteoarthritis Measure (JKOM)

* Compare the amount of change between screening (before consumption) and 12 weeks after consumption
Key secondary outcomes 1. JKOM
Assess the total score of JKOM and the scores of visual analogue scale (VAS), pain and stiffness in knees, conditions in daily life, general activities, and health conditions

2. The Japanese Orthopaedic Association score for osteoarthritic knees (JOA)
Assess JOA scores (the average in both legs, right leg, and left leg)

3. Subjective symptoms related to knee pains (VAS)

4. The 30-second chair stand test
Assess the number of times of standing up from the chair for 30 seconds

5. The 10-meter walking test
Assesse walking speed, the number of steps, stride length, and waking rate (the number of steps per time)

6. Blood test
Assess high sensitivity C-reactive protein, cleavage of type II collagen, and myoglobin

*1-6 Assess the items at screening (before consumption) and 4, 8, and 12 weeks after consumption and calculate the amount of change or rate of change. However, the total score of JKOM assesses only the value and rate of change at 12 weeks after consumption.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Duration: 12 weeks
Test Material: Active tablets
Dosage: Take 6 tablets with water or warm water after breakfast

* If you forget to take the tablets, take tablets as soon as you remember within the day.
Interventions/Control_2 Duration: 12 weeks
Test Material: Placebo tablets
Dosage: Take 6 tablets with water or warm water after breakfast

* If you forget to take the tablets, take tablets as soon as you remember within the day.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Healthy Japanese adult subjects

2. Subjects who are experiencing discomfort in the knee joint; however, subjects who are not diagnosed with any diseases by a physician

3. Subjects who are judged as eligible to participate in the study by the physician

4. Within the subjects who met the 1st to 3rd inclusion criteria, subjects who are judged in the Kellgren-Lawrence grade (KL grade) either 0 or 1 in X-ray at screening (before consumption)

5. Within the subjects who met the 4th inclusion criteria, subjects whose total scores of JKOM are relatively high at screening (before consumption)
Key exclusion criteria 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction

2. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

3. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily

4. Subjects who are currently taking medications (including herbal medicines) and supplement
* Particularly taking anticoagulants such as warfarin

5. Subjects who experience palpitations when they walk fast

6. Subjects who are allergic to medicines and/or the test food related products

7. Subjects who are pregnant, breast-feeding, or planning to become pregnant

8. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial

9. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo YAMAMOTO
Organization ORTHOMEDICO Inc.
Division name CEO
Zip code
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL 03-3818-0610
Email kazu@orthomedico.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoko SUZUKI
Organization ORTHOMEDICO Inc.
Division name R&D Department
Zip code
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL 03-3818-0610
Homepage URL
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization DHC Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Medical Corporation Seishinkai, Takara Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information
2018 Year 07 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 No longer recruiting
Date of protocol fixation
2018 Year 07 Month 09 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 07 Month 19 Day
Last modified on
2018 Year 12 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038134

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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