UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017127
Receipt number R000019866
Scientific Title Effects of soy lecithin on middle-aged women's tiredness
Date of disclosure of the study information 2015/04/13
Last modified on 2023/04/21 10:34:57

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Basic information

Public title

Effects of soy lecithin on middle-aged women's tiredness

Acronym

Effects of soy lecithin on middle-aged women's tiredness

Scientific Title

Effects of soy lecithin on middle-aged women's tiredness

Scientific Title:Acronym

Effects of soy lecithin on middle-aged women's tiredness

Region

Japan


Condition

Condition

menopausal symptoms

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the effects of soy lecithin on middle-aged women's tiredness

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

subjective and objective fatigue

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

Treatment

Type of intervention

Food

Interventions/Control_1

8-week treatment with 1200 mg of soy lecithin

Interventions/Control_2

8-week treatment with 600 mg of soy lecithin

Interventions/Control_3

8-week treatment with 0 mg of soy lecithin

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

40 years-old <=

Age-upper limit

60 years-old >

Gender

Female

Key inclusion criteria

women with tiredness

Key exclusion criteria

women who are treated with estrogens, Kampo medicine, psychotropic agents etc.

Target sample size

90


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masakazu Terauchi

Organization

Tokyo Medical and Dental University

Division name

Department of Women's Health

Zip code


Address

Yushima 1-5-45, Bunkyo, Tokyo

TEL

03-5803-4605

Email

teragyne@tmd.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masakazu Terauchi

Organization

Tokyo Medical and Dental University

Division name

Department of Women's Health

Zip code


Address

Yushima 1-5-45, Bunkyo, Tokyo

TEL

03-5803-4605

Homepage URL


Email

teragyne@tmd.ac.jp


Sponsor or person

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name



Funding Source

Organization

Tokyo Medical and Dental University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



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



Other administrative information

Date of disclosure of the study information

2015 Year 04 Month 13 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

2014 Year 09 Month 03 Day

Date of IRB

2014 Year 09 Month 03 Day

Anticipated trial start date

2015 Year 04 Month 14 Day

Last follow-up date

2015 Year 07 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 04 Month 13 Day

Last modified on

2023 Year 04 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019866


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name