Unique ID issued by UMIN | UMIN000054270 |
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Receipt number | R000061971 |
Scientific Title | A Study on the Effect of Test Food on Lower Back Problems -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study- |
Date of disclosure of the study information | 2024/04/26 |
Last modified on | 2024/04/26 14:55:41 |
A Study on the Effect of Test Food on Lower Back Problems
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
A Study on the Effect of Test Food on Lower Back Problems
A Study on the Effect of Test Food on Lower Back Problems
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
A Study on the Effect of Test Food on Lower Back Problems
Japan |
No
Adult |
Others
NO
To confirm the effect of test food on lower back problems
Efficacy
assessment of lower back problems
Questionnaire
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
Active food, 8 weeks consumption
Placebo food, 8 weeks consumption
20 | years-old | <= |
75 | years-old | > |
Male and Female
1)Males and females aged 20 to 74 years-old with discomfort of lower back.
2)Subjects who can make self-judgment and are voluntarily giving written informed consent.
Subjects (who)
1) are currently attending hospital or have a current medical history of a disease that could affect the study.
2)underwent surgery for chronic pain in joints, ligament injury or meniscus injury.
3)with artificial joints, etc.
4)take joint related medicines (such as poultices, liniments, and/or analgesics, etc.) three or more times a week.
5)can't stop using drugs and/or supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) affecting joints during the study period.
6) are pregnant or planning to become pregnant or breastfeed during the study period.
7)have a history of and/or contract serious diseases (eg, liver disease, kidney disease, digestive disease, heart disease, respiratory disease, endocrine disease, metabolic disease and/or joint disease).
8)have allergy to ingredients of test foods.
9)are participating or intend to participate in other clinical trials that may affect the study at the time of commencement of the study.
10)are judged as unsuitable for the current study by the investigator for other reasons.
66
1st name | Saeko |
Middle name | |
Last name | Isaka |
TOYO SHINYAKU Co., Ltd.
Clinical and analytical research center
841-0005
7-28 Yayoigaoka, Tosu-shi, Saga
0942-81-3555
isakas@toyoshinyaku.co.jp
1st name | Nobutaka |
Middle name | |
Last name | Kusaba |
TOYO SHINYAKU Co., Ltd.
Clinical and analytical research center
841-0005
7-28 Yayoigaoka, Tosu-shi, Saga
0942-81-3555
gakujutsu@toyoshinyaku.co.jp
TOYO SHINYAKU Co., Ltd.
TOYO SHINYAKU Co., Ltd.
Profit organization
Miura Clinic, Medical Corporation Kanonkai IRB
9F Higashitenma building, 1-7-17 Higashitenma, Kita-ku, Osaka, Osaka
06-6135-5200
mterashima@miura-cl.jp
NO
2024 | Year | 04 | Month | 26 | Day |
Unpublished
Preinitiation
2024 | Year | 04 | Month | 19 | Day |
2024 | Year | 04 | Month | 25 | Day |
2024 | Year | 04 | Month | 26 | Day |
2024 | Year | 10 | Month | 31 | Day |
2024 | Year | 04 | Month | 26 | Day |
2024 | Year | 04 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061971
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