UMIN-CTR Clinical Trial

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

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Basic information

Public title

Verification of the effects of plant extract intake on sexual function and menopausal symptoms

Acronym

Verification of the effects of plant extract intake on sexual function and menopausal symptoms

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

Scientific Title:Acronym

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

Region

Japan


Condition

Condition

healthy adult woman

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to examine the effects of test food intake on sexual function and menopausal symptoms.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1.FSFI
2.Kupperman Women's Health Survey

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Continuous intake of test food A for 4 weeks

Interventions/Control_2

Continuous intake of test food B for 4 weeks

Interventions/Control_3

Continuous intake of placebo food for 4 weeks

Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

35 years-old <=

Age-upper limit

60 years-old >

Gender

Female

Key inclusion criteria

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.

Key exclusion criteria

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

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Daisuke
Middle name
Last name Ochitani

Organization

BHN Co., Ltd

Division name

Evidence-Based Functional Food Business Promotion Office

Zip code

101-0054

Address

1-16, Kanda Nishiki-cho, Chiyoda-ku, Tokyo, 101-0054, Japan

TEL

03-5281-5661

Email

d-ochitani@bhn.co.jp


Public contact

Name of contact person

1st name Daisuke
Middle name
Last name Ochitani

Organization

BHN Co., Ltd

Division name

Evidence-Based Functional Food Business Promotion Office

Zip code

101-0054

Address

1-16, Kanda Nishiki-cho, Chiyoda-ku, Tokyo, 101-0054, Japan

TEL

03-5281-5661

Homepage URL


Email

d-ochitani@bhn.co.jp


Sponsor or person

Institute

Others

Institute

Department

Personal name



Funding Source

Organization

Others

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Shiba Palace Clinic Ethics Review Committee

Address

DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho Minato-ku, Tokyo

Tel

03-5408-1599

Email

shiba_palace@s-palace-clinic.com


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2023 Year 05 Month 29 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2023 Year 04 Month 10 Day

Date of IRB

2023 Year 04 Month 27 Day

Anticipated trial start date

2023 Year 05 Month 30 Day

Last follow-up date

2023 Year 07 Month 13 Day

Date of closure to data entry

2023 Year 07 Month 20 Day

Date trial data considered complete

2023 Year 07 Month 28 Day

Date analysis concluded

2023 Year 10 Month 01 Day


Other

Other related information



Management information

Registered date

2023 Year 05 Month 22 Day

Last modified on

2023 Year 10 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058282