UMIN-CTR Clinical Trial

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

Objectives
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

Assessment
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

Base
Study type	Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute	ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization	YASOUKOUSO.Co.,Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
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
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) 南町医院 (東京都) Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information	2021 Year 01 Month 18 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	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

Progress
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
Other related information

Management information
Registered date	2021 Year 01 Month 18 Day
Last modified on	2022 Year 10 Month 28 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049144