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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000017127
Receipt No. R000019866
Official scientific title of the study Effects of soy lecithin on middle-aged women's tiredness
Date of disclosure of the study information 2015/04/13
Last modified on 2015/10/13

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Basic information
Official scientific title of the study Effects of soy lecithin on middle-aged women's tiredness
Title of the study (Brief title) Effects of soy lecithin on middle-aged women's tiredness
Region
Japan

Condition
Condition menopausal symptoms
Classification by specialty
Obsterics 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 Masakazu Terauchi
Organization Tokyo Medical and Dental University
Division name Department of Women's Health
Address Yushima 1-5-45, Bunkyo, Tokyo
TEL 03-5803-4605
Email teragyne@tmd.ac.jp

Public contact
Name of contact person Masakazu Terauchi
Organization Tokyo Medical and Dental University
Division name Department of Women's Health
Address Yushima 1-5-45, Bunkyo, Tokyo
TEL 03-5803-4605
Homepage URL
Email teragyne@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

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)

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

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2014 Year 09 Month 03 Day
Anticipated trial start date
2015 Year 04 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2015 Year 04 Month 13 Day
Last modified on
2015 Year 10 Month 13 Day


Link to view the page
URL(English) https://upload.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


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