Unique ID issued by UMIN | UMIN000051120 |
---|---|
Receipt number | R000058282 |
Scientific Title | A randomized, double-blind, placebo-controlled, parallel-group study on the effects of plant extract intake on sexual function and menopausal symptoms in healthy women |
Date of disclosure of the study information | 2023/05/29 |
Last modified on | 2023/10/27 16:29:57 |
Verification of the effects of plant extract intake on sexual function and menopausal symptoms
Verification of the effects of plant extract intake on sexual function and menopausal symptoms
A randomized, double-blind, placebo-controlled, parallel-group study on the effects of plant extract intake on sexual function and menopausal symptoms in healthy women
A randomized, double-blind, placebo-controlled, parallel-group study on the effects of plant extract intake on sexual function and menopausal symptoms in healthy women
Japan |
healthy adult woman
Not applicable | Adult |
Others
NO
The purpose of this study is to examine the effects of test food intake on sexual function and menopausal symptoms.
Efficacy
1.FSFI
2.Kupperman Women's Health Survey
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
3
Prevention
Food |
Continuous intake of test food A for 4 weeks
Continuous intake of test food B for 4 weeks
Continuous intake of placebo food for 4 weeks
35 | years-old | <= |
60 | years-old | > |
Female
1) Japanese women aged 35 to 60 at the time of obtaining written consent
2) Those who have sexual intercourse more than twice a month
3) Subjects who have received a sufficient explanation of the purpose and content of the research, are capable of giving consent, have fully understood the study, voluntarily applied to participate in the study, and agreed to participate in the study in writing.
1.Subjects with systolic blood pressure of 180 mmH or higher
2.Subjects who are likely to develop a serious allergy to food
3.Currently pregnant or breastfeeding. Or a person who may have such a possibility during the test period
4.Liver/kidney/cardiac disease, respiratory disorder, endocrine disorder, metabolic disorder, neurological disorder, consciousness disorder, diabetes, brain disease, malignant tumor, immune disease, serious disease such as heart disease, thyroid disease, other metabolic diseases Those who have a serious current disease such as disease or a history
5.Subjects who are currently undergoing drug treatment, outpatient treatment, diet therapy, or exercise therapy for any serious or chronic disease.
6.Subjects using health foods, supplements, and medicines that affect menopausal symptoms and sexual function
7.Subjects with current or past drug or alcohol dependence
8.Subjects who are undergoing hospital visits due to mental disorders (depression, etc.), sleep disorders, etc., or who have a history of mental disorders in the past
9.Subjects with irregular life rhythm due to night work or shift work
10.Subjects whose lifestyle habits may change during the test period (long-term travel, etc.)
11.Subjects with extremely irregular lifestyles such as eating and sleeping
12.Those who have an extremely unbalanced diet
13.Subjects who participated in other clinical trials (research) within 3 months prior to the date of consent acquisition, or those who plan to participate in other clinical trials (research) during the trial period
14.Subjects who have collected or donated more than 200 mL of blood within 1 month or 400 mL of blood within 3 months prior to the date of obtaining informed consent.
15.Subjects who have difficulty keeping track of various questionnaires
16.Subjects judged to be unsuitable as subjects based on the results of SCR
17.Others who are judged by the principal investigator to be unsuitable as subjects
30
1st name | Daisuke |
Middle name | |
Last name | Ochitani |
BHN Co., Ltd
Evidence-Based Functional Food Business Promotion Office
101-0054
1-16, Kanda Nishiki-cho, Chiyoda-ku, Tokyo, 101-0054, Japan
03-5281-5661
d-ochitani@bhn.co.jp
1st name | Daisuke |
Middle name | |
Last name | Ochitani |
BHN Co., Ltd
Evidence-Based Functional Food Business Promotion Office
101-0054
1-16, Kanda Nishiki-cho, Chiyoda-ku, Tokyo, 101-0054, Japan
03-5281-5661
d-ochitani@bhn.co.jp
Others
Others
Profit organization
Shiba Palace Clinic Ethics Review Committee
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho Minato-ku, Tokyo
03-5408-1599
shiba_palace@s-palace-clinic.com
NO
2023 | Year | 05 | Month | 29 | Day |
Unpublished
Completed
2023 | Year | 04 | Month | 10 | Day |
2023 | Year | 04 | Month | 27 | Day |
2023 | Year | 05 | Month | 30 | Day |
2023 | Year | 07 | Month | 13 | Day |
2023 | Year | 07 | Month | 20 | Day |
2023 | Year | 07 | Month | 28 | Day |
2023 | Year | 10 | Month | 01 | Day |
2023 | Year | 05 | Month | 22 | Day |
2023 | Year | 10 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058282