UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031815 |
|---|---|
| Receipt number | R000036335 |
| Scientific Title | Effectiveness of natural S-equol supplement for premenstrual symptoms: a randomized, double-blind, placebo-controlled trial |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2026/03/26 09:50:08 |
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Basic information
Public title
Effectiveness of natural S-equol supplement for premenstrual symptoms: a randomized, double-blind, placebo-controlled trial
Acronym
Effectiveness of equol for PMS (ESPRESSO study)
Scientific Title
Effectiveness of natural S-equol supplement for premenstrual symptoms: a randomized, double-blind, placebo-controlled trial
Scientific Title:Acronym
Effectiveness of equol for PMS (ESPRESSO study)
Region
| Japan |
Condition
Condition
PMS
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of equol supplements with premenstrual symptoms using a double-blind, randomized, placebo-controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Premenstrual symptoms
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
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Natural S-equol supplement
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
| 20 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
With moderate to severe PMS or PMDD
Equol non-producer
Without severe complications
Key exclusion criteria
Hypersensitive to soy foods
Target sample size
124
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Takeda |
Organization
Kindai University
Division name
Center for Traditional Asian Medicine
Zip code
589-8511
Address
377-2, Ohno-Higashi, Osaka-Sayama, Osaka, Japan
TEL
072-366-0221
take@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Takeda |
Organization
Kindai University
Division name
Center for Traditional Asian Medicine
Zip code
589-8511
Address
377-2, Ohno-Higashi, Osaka-Sayama, Osaka, Japan
TEL
072-366-0221
Homepage URL
take@med.kindai.ac.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Co., Ltd.
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
Kindai University
Address
377-2, Ohno-Higashi, Osaka-Sayama, Osaka 589-8511, Japan
Tel
072-366-0221
zizen@med.kindai.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
| 2018 | Year | 04 | Month | 01 | 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
| 2018 | Year | 03 | Month | 19 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2025 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2025 | Year | 09 | Month | 08 | Day |
Other
Other related information
Due to the termination of AMED funding, the research was changed to research funded by Otsuka Pharmaceutical.
Management information
Registered date
| 2018 | Year | 03 | Month | 20 | Day |
Last modified on
| 2026 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036335
