UMIN-CTR Clinical Trial

Public title

Effects of consumption of the test food in healthy Japanese subjects with discomfort of knee and/or waist joints

Acronym

Effects of consumption of the test food in healthy Japanese subjects with discomfort of knee and/or waist joints

Scientific Title

Effects of consumption of the test food in healthy Japanese subjects with discomfort of knee and/or waist joints: a randomized, placebo-controlled, double-blind, parallel-group comparison study

Scientific Title:Acronym

Effects of consumption of the test food in healthy Japanese subjects with discomfort of knee and/or waist joints

Region

Japan

Condition

Healthy Japanese subjects

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To verify the effects of consumption of the test food in healthy Japanese subjects with discomfort of knee and/or waist joints

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

The measured value of the Japanese Knee Osteoarthritis Measure (JKOM) score at eight weeks after consumption (8w)

Key secondary outcomes

1. The measured value of JKOM score at four weeks after consumption (4w)
2. The change of the JKOM score from screening (before consumption; Scr) to 4w and 8w
3. The measured values at 4w and 8w and amounts of changes from Scr to 4w and 8w of the following items:
3-1. JKOM
visual analog scale (VAS), the score of pain and stiffness in knees, the score of condition in daily life, the score of general activities, and the score of health conditions
3-2. Japan Low Back Pain Evaluation Questionnaire (JLEQ)
VAS, total score, low back pain related to activity of daily living, problems due to low back pain, and health and psychological condition
3-3. Japanese Orthopaedic Association (JOA) knee score
JOA score [average of both foot (right and left), left foot, and right foot], pain on walkin g [average of both foot (right and left), left foot, and right foot], pain on ascending or descending stairs [average of both foot (right and left), left foot, and right foot], range of motion [average of both foot (right and left), left foot, and right foot], joint effusion [average of both foot (right and left), left foot, and right foot]
3-4. JOA lumbar spine score
subjective symptoms score, objective symptoms score ,activities of daily living, and urinary bladder function
3-5. VAS score for leg pain
3-6. the number of times of standing up from the chair for 30 seconds
3-7. walking speed
3-8. the number of steps
3-9. stride length
3-10. waking rate
4. The values of the following items at 4w and 8w: individual items of the JKOM questionnaire, individual items of the JLEQ questionnaire, individual items of the JOA knee score, individual items of the JOA lumbar spine score

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Duration: Eight weeks
Test food: food containing a mixture of tamarind and turmeric (normal dose)
Administration: Take two capsules per day after breakfast with water

* Daily dose should be taken within the day. If you forget to take the capsule, take it as soon as you remember within the day.

Interventions/Control_2

Duration: Eight weeks
Test food: food containing a mixture of tamarind and turmeric (low dose)
Administration: Take two capsules per day after breakfast with water

* Daily dose should be taken within the day. If you forget to take the capsule, take it as soon as you remember within the day.

Interventions/Control_3

Duration: Eight weeks
Test food: Placebo
Administration: Take two capsules per day after breakfast with water

* Daily dose should be taken within the day. If you forget to take the capsule, take it as soon as you remember within the day.

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Japanese
2. Healthy subjects
3. Subjects who are experiencing discomfort in the knee and waist joints
4. Subjects who are judged as eligible to participate in the study by the physician
5. Within the subjects who met the 4th inclusion criteria, subjects who are judged in the Kellgren-Lawrence grade (KL grade) either 0 or 1 in X-ray at Scr
6. Within the subjects who met the 5th inclusion criteria, subjects whose JKOM score are relatively high at Scr

Key exclusion criteria

1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Subjects who are undergoing medical treatment of knee disease such as knee osteoarthritis
4. Subjects who currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
5. Subjects who take ""Foods for Specified Health Uses,"" ""Foods with Functional Claims,"" or other functional food/beverage in daily use
6. Subjects who currently taking medications (including herbal medicines) and supplements
7. Subjects who are allergic to medicines and/or the test food related products, particularly turmeric and tamarind
8. Subjects who are pregnant, lactation, or planning to become pregnant
9. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial
10. Subjects who are judged as ineligible to participate in the study by the physician

Target sample size

90

Name of lead principal investigator

1st name	Tsuyoshi
Middle name
Last name	Takara

Organization

Medical Corporation Seishinkai, Takara Clinic

Division name

Director

Zip code

141-0022

Address

9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.

TEL

03-5793-3623

Email

t-takara@takara-clinic.com

Name of contact person

1st name	Naoko
Middle name
Last name	Suzuki

Organization

ORTHOMEDICO Inc.

Division name

R&D Department

Zip code

112-0002

Address

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.

TEL

03-3818-0610

Homepage URL

Email

nao@orthomedico.jp

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name

Organization

YASOUKOUSO.Co.,Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Medical Corporation Seishinkai, Takara Clinic

Nerima Medical Association, Minami-machi Clinic

Name of secondary funder(s)

Organization

the ethical committee of the Takara Clinic, Medical Corporation Seishinkai

Address

9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.

Tel

03-5793-3623

Email

IRB@takara-clinic.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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)

南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)

Date of disclosure of the study information

2021

Year

01

Month

18

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

99

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

Recruitment status

Completed

Date of protocol fixation

2021

Year

01

Month

13

Day

Date of IRB

2021

Year

01

Month

13

Day

Anticipated trial start date

2021

Year

01

Month

18

Day

Last follow-up date

2021

Year

06

Month

26

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2021

Year

01

Month

18

Day

Last modified on

2022

Year

10

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049144