Unique ID issued by UMIN | UMIN000023486 |
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Receipt number | R000027056 |
Scientific Title | The verification study for QOL improvement effects on urination: a randomized double-blind, parallel-group, placebo-controlled study |
Date of disclosure of the study information | 2016/08/04 |
Last modified on | 2018/11/15 12:25:34 |
The verification study for QOL improvement effects on urination: a randomized double-blind, parallel-group, placebo-controlled study
The verification study for QOL improvement effects for urination
The verification study for QOL improvement effects on urination: a randomized double-blind, parallel-group, placebo-controlled study
The verification study for QOL improvement effects for urination
Japan |
Healthy adults
Not applicable | Adult |
Others
NO
To identify effects of the test food ingestion on the QOL improvement associated with urination
Safety,Efficacy
King's Health Questionnaire
*1 Answer the questionnaire at 0 week and at 4 and 8 weeks after the ingestion
Overactive Bladder Symptom Score (OABSS)
*1 Perform OABSS at 0 week and at 4 and 8 weeks after the ingestion
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
3
Treatment
Food |
Duration: 8 weeks
Test material: Seaberry extract-P (high-dose: 400 mg)
Dose: Take one capsule, twice a day
Administration: Take one capsule after breakfast and after dinner
Duration: 8 weeks
Test material: Seaberry extract-P (low-dose: 200 mg)
Dose: T Take one capsule, twice a day
Administration: Take one capsule after breakfast and after dinner
Duration: 8 weeks
Test material: Placebo
Dose: Take one capsule, twice a day
Administration: Take one capsule after breakfast and after dinner
40 | years-old | <= |
Not applicable |
Male and Female
1. Healthy Japanese adults of 40 years old and over
2. The frequency of urination is eight and more per day
1. At least one previous medical history of malignant tumor, heart failure or myocardial infarction
2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases
3. Currently taking medicines and/or herbal medicines
4. Those who are taking Food for Specified Health Uses , Food with Function Claims a daily basis
5. Allergic to medicines or foods related to the test food of this trial
6. Pregnant, lactating, or planning to get pregnant during the trial period
7. Enrolled into other clinical trials within the last 3 months before agreeing to participate in this trial
8. Judged unsuitable for participating in this trial by physician
45
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.
ORYZA OIL & FAT CHEMICAL 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 | 08 | Month | 04 | Day |
Published
Takara T, Yamamoto K, Suzuki N, Shimoda H. Seaberry extract with ursolic acid improves anxiety about urinary dysfunction in Japanese adults. Functional Foods Health and Disease. 2017; 7(12): 901-922
Completed
2016 | Year | 08 | Month | 02 | Day |
2016 | Year | 08 | Month | 04 | Day |
2017 | Year | 01 | Month | 22 | Day |
2016 | Year | 08 | Month | 04 | Day |
2018 | Year | 11 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027056
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