Unique ID issued by UMIN | UMIN000048484 |
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Receipt number | R000055251 |
Scientific Title | An examination study of the methods for evaluating the effects of subjective symptoms by consuming the test food in Japanese subjects with knee pain or discomfort: a randomized, open-labeled study |
Date of disclosure of the study information | 2022/07/27 |
Last modified on | 2023/03/29 13:04:32 |
An examination study of the methods for evaluating the effects of subjective symptoms by consuming the test food in Japanese subjects with knee pain or discomfort
An examination study of the methods for evaluating the effects of subjective symptoms by consuming the test food in Japanese subjects with knee pain or discomfort
An examination study of the methods for evaluating the effects of subjective symptoms by consuming the test food in Japanese subjects with knee pain or discomfort: a randomized, open-labeled study
An examination study of the methods for evaluating the effects of subjective symptoms by consuming the test food in Japanese subjects with knee pain or discomfort
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To investigate the methods of evaluating the effect of subjective symptom improvement when the subjects with knee pain and discomfort consume the test food.
Efficacy
Exploratory
Pragmatic
Not applicable
Assessment items for knee joint pain or discomfort
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
Institution is not considered as adjustment factor.
YES
No need to know
2
Prevention
Food |
Intake of test supplement 1 for 12 consecutive weeks
Intake of test supplement 2 for 12 consecutive weeks
40 | years-old | <= |
70 | years-old | > |
Male and Female
1. Japanese
2. Men or women
3. Subjects aged between 40 and 69
4. Healthy subjects
5. Subjects who feel knee discomfort (and/or pain) at rest or movement
6. Subjects whose both knees are judged in the Kellgren-Lawrence grade (KL grade) as either 0 or 1 in standing position X-ray at screening (before consumption: Scr)
Subjects (who/whose)
1.are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2.have pacemaker or an implantable cardioverter defibrillator
3.are undergoing medical treatment or have a medical history for chronic disease such as arrhythmia, hepatopathy, nephropathy, cerebrovascular disorder, rheumatism, diabetes, dyslipidemia, hypertension, or hyperuricemia
4.have undergone or need to undergo joint surgery
5.have undergone intra-articular injections (e.g. hyaluronic acid or steroid) within a year before the agreement to participate, or who need to undergo them during this trial
6.have a history of markedly abnormal in laboratory values or cardiopulmonary function
7.intensely exercise with excessive load on joints
8.have a medical history of diseases associated with bone or joint such as fracture, sprain, arthritis, or periarthritis within a year before the agreement to participate
9.use a cane or joint support, or may use them during this trial
10.laboratory or measured values markedly deviate from the reference values at Scr
11.are judged as ineligible to participate based on a background investigation
12.usually use "Foods for Specified Health Uses," or "Foods with Functional Claims" {e.g. N-acetylglucosamine, proteoglycan from salmon nasal cartilage (SNC), undenatured type II collagen from SNC, glucosamine hydrochloride, curcumin, elastin peptide from skipjack, or collagen peptide}
13.currently taking medications (including herbal medicines)
14.are allergic to medicines or the test food related products
15.are pregnant or lactating / plan to become pregnant during this trial
16.have or are strongly suspected to have an infectious disease such as COVID-19
17.have been enrolled in other clinical trials within the last 28 days before the agreement to participate or plan to participate another trial during this trial
18.are judged as ineligible to participate by the principle investigational doctor
30
1st name | Tsuyoshi |
Middle name | |
Last name | Takara |
Medical Corporation Seishinkai, Takara Clinic
Director
141-0022
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
03-5793-3623
t-takara@takara-clinic.com
1st name | Naoko |
Middle name | |
Last name | Suzuki |
ORTHOMEDICO Inc.
R&D Department
112-0002
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO Inc.
FANCL CORPORATION
Profit organization
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
03-5793-3623
IRB@takara-clinic.com
NO
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)
2022 | Year | 07 | Month | 27 | Day |
Unpublished
32
Completed
2022 | Year | 07 | Month | 20 | Day |
2022 | Year | 07 | Month | 20 | Day |
2022 | Year | 07 | Month | 28 | Day |
2022 | Year | 12 | Month | 15 | Day |
2022 | Year | 07 | Month | 27 | Day |
2023 | Year | 03 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055251
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