Unique ID issued by UMIN | UMIN000022084 |
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Receipt number | R000025462 |
Scientific Title | Quality of life improvement of mild knee pain effect verification study in healthy Japanese adults: a double-blind randomized controlled trial |
Date of disclosure of the study information | 2016/04/26 |
Last modified on | 2017/11/20 11:22:34 |
Quality of life improvement of mild knee pain effect verification study in healthy Japanese adults: a double-blind randomized controlled trial
Quality of life improvement of mild knee pain effect verification study in healthy Japanese adults
Quality of life improvement of mild knee pain effect verification study in healthy Japanese adults: a double-blind randomized controlled trial
Quality of life improvement of mild knee pain effect verification study in healthy Japanese adults
Japan |
Healthy adults
Not applicable | Adult |
Others
NO
To verify the mild knee pain improvement effect due to the ingestion of the test food
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Japanese Knee Osteoarthritis Measure (JKOM)
*Measuring point: at 0 week and 4 weeks after ingestion
The scoring system of the Japanese Orthopaedic Association (JOA)
High sensitivity C-reactive protein (hs-CRP)
*Measuring point: at 0 week and 4 weeks after ingestion
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
3
Treatment
Food |
Duration: 4 weeks
Test material: Krill oil capsule
Dose: 4 capsules, once a day Administration: Take 4 capsules after breakfast
Duration: 4 weeks
Test material: Krill oil and safflower oil capsule
Dose: 4 capsules, once a day Administration: Take 4 capsules after breakfast
Duration: 4 weeks
Test material: Placebo capsule
Dose: 4 capsules, once a day Administration: Take 4 capsules after breakfast
20 | years-old | <= |
Not applicable |
Male and Female
1. Healthy Japanese adults
2. Persons have mild knee pain
1. At least one previous medical history of malignant tumor, heart failure or myocardial infarction
2. Currently under the treatment for either atrial fibrillation, cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, knee osteoarthritis, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases.
3. Currently taking medicines (include herbal medicines), and/or supplements, particularly taking acetylsalicylic acid or warfarin medicines
4. Allergic to medicines or foods related to the test food of this trial (shellfish and gelatin allergic for the test food contains crustacean-originating ingredient and is coated with gelatin-containing capsule film.)
5. Pregnant, lactating, or planning to get pregnant during the trial period
6. Enrolled into other clinical trials within the last 3 months before agreeing to participate in this trial
7. Judged unsuitable for participating in this trial by physician
75
1st name | |
Middle name | |
Last name | Kazuo YAMAMOTO |
ORTHOMEDICO, Inc.
R&D Department
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
03-3818-0610
kazu@orthomedico.jp
1st name | |
Middle name | |
Last name | Naoko SUZUKI |
ORTHOMEDICO, Inc.
R&D Department
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO, Inc.
Sunsho Pharmaceutical Co., Ltd.
Profit organization
Seishin-kai Medical Association Inc, Takara Medical Clinic.
NO
医療法人社団 盛心会 タカラクリニック (東京都)
Seishin-kai Medical Association Inc, Takara Medical Clinic (Tokyo)
2016 | Year | 04 | Month | 26 | Day |
Published
Watanabe H, Matahira Y, Suzuki N, Takara T. Effects of Ingestion of Krill Oil on Quality of Life Related to Mild Knee Pain-A Randomized Double-blind Placebo-controlled Trial-. Jpn Pharmacol Ther. 2017; 45(6): 999-1026.
Completed
2016 | Year | 04 | Month | 18 | Day |
2016 | Year | 04 | Month | 27 | Day |
2016 | Year | 11 | Month | 30 | Day |
2016 | Year | 11 | Month | 30 | Day |
2016 | Year | 12 | Month | 10 | Day |
2016 | Year | 12 | Month | 16 | Day |
2016 | Year | 04 | Month | 26 | Day |
2017 | Year | 11 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025462
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