UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019113 |
|---|---|
| Receipt number | R000022096 |
| Scientific Title | Effects of soy milk on insomnia in middle-aged women |
| Date of disclosure of the study information | 2015/09/25 |
| Last modified on | 2023/04/01 11:46:33 |
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Basic information
Public title
Effects of soy milk on insomnia in middle-aged women
Acronym
Effects of soy milk on insomnia in middle-aged women
Scientific Title
Effects of soy milk on insomnia in middle-aged women
Scientific Title:Acronym
Effects of soy milk on insomnia in middle-aged women
Region
| Japan |
Condition
Condition
menopausal symptoms
insomnia
Classification by specialty
| Obstetrics and Gynecology | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of soy milk on subjective and objective sleep parameters in middle-aged women with insomnia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
St. Mary's Hospital Sleep Questionnaire, Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale, and actigraphy, after 8 weeks of treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
8-week treatment with 800 mL/day of soy milk
Interventions/Control_2
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
| 40 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
women with subjective insomnia scoring 6 or more on the Athens Insomnia Scale
Key exclusion criteria
women who are treated with estrogens, Kampo medicine, psychotropic agents etc.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masakazu |
| Middle name | |
| Last name | Terauchi |
Organization
Masakazu Terauchi
Division name
Department of Women's Health
Zip code
1138510
Address
Yushima 1-5-45, Bunkyo, Tokyo
TEL
03-5803-4605
teragyne@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Masakazu |
| Middle name | |
| Last name | Terauchi |
Organization
Tokyo Medical and Dental University
Division name
Department of Women's Health
Zip code
1138510
Address
Yushima 1-5-45, Bunkyo, Tokyo
TEL
03-5803-4605
Homepage URL
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
Tokyo Medical and Dental University
Address
Yushima 1-5-45, Bunkyo, Tokyo
Tel
03-3813-6111
info.bec@tmd.ac.jp
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 | 09 | Month | 25 | 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
| 2015 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2015 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | 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 | 09 | Month | 25 | Day |
Last modified on
| 2023 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022096
