UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017821
Receipt number R000020590
Scientific Title Single center, double-blind, randomized, parallel trial to evaluate the efficacy of rhizopus koji extract containing food in subjects with menopause symptom
Date of disclosure of the study information 2015/06/24
Last modified on 2018/05/01 12:10:14

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Basic information

Public title

Single center, double-blind, randomized, parallel trial to evaluate the efficacy of rhizopus koji extract containing food in subjects with menopause symptom

Acronym

Evaluation study of the efficacy for menopause symptom

Scientific Title

Single center, double-blind, randomized, parallel trial to evaluate the efficacy of rhizopus koji extract containing food in subjects with menopause symptom

Scientific Title:Acronym

Evaluation study of the efficacy for menopause symptom

Region

Japan


Condition

Condition

menopause symptom

Classification by specialty

Medicine in general Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of rhizopus koji extract containing food in improving menopause symptom after 4-week intake

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Kupffer man menopausal index ( Abe modification)

Key secondary outcomes

SDS,STAI


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration


Blocking

YES

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

rhizopus koji extract containing food

Interventions/Control_2

Placebo

Interventions/Control_3


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

45 years-old <=

Age-upper limit

60 years-old >

Gender

Female

Key inclusion criteria

(1)Japanese female ages 45-59 years old (inclusive)
(2)Subjects with Kupffer man menopausal index more than 23 scores
(3)Willing and able to provide signed written informed consent

Key exclusion criteria

(1)Subjects with severe hepatic, renal, cardiac, gastrointestinal, hematologic, endocrine and metabolic diseases / disorders
(2)Subjects with history of sensitivity to the ingredients
(3)Subjects who had participated in other clinical trials including drug and food within 1 month.
(4)Pregnant, lactating women or willing to be pregnancy during the study
(5)Any candidate considered to be unsuitable for enrollment in the opinion of the principal investigator

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masaki Nishiyama

Organization

Kaiyu Clinic

Division name

Kaiyu Clinic

Zip code


Address

3-3-6 Sagimiya, Nakano-ku, Tokyo

TEL

03-5356-6450

Email

abe@kaiyuclinic.com


Public contact

Name of contact person

1st name
Middle name
Last name Shigeru Imai

Organization

CROee Inc.

Division name

Evidence Division

Zip code


Address

1-13-23 Minami-Ikebukuro, Toshima-ku, Tokyo

TEL

03-5953-2108

Homepage URL


Email

imai@croee.com


Sponsor or person

Institute

USHIKOSHI RESEARCH INSTITUTE FOR PHYSIOLOGY CO.,LTD.

Institute

Department

Personal name



Funding Source

Organization

USHIKOSHI RESEARCH INSTITUTE FOR PHYSIOLOGY CO.,LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

カイユウ診療所(東京都)


Other administrative information

Date of disclosure of the study information

2015 Year 06 Month 24 Day


Related information

URL releasing protocol


Publication of results

Published


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

Main results already published

Date of protocol fixation

2015 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2015 Year 06 Month 26 Day

Last follow-up date

2015 Year 08 Month 05 Day

Date of closure to data entry

2015 Year 08 Month 26 Day

Date trial data considered complete

2015 Year 08 Month 26 Day

Date analysis concluded

2015 Year 12 Month 25 Day


Other

Other related information



Management information

Registered date

2015 Year 06 Month 05 Day

Last modified on

2018 Year 05 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020590


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name