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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031815
Receipt No. 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 2019/09/20

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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
Obsterics 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
Email 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
Email take@med.kindai.ac.jp

Sponsor
Institute Otsuka Pharmaceutical Co., Ltd.
Institute
Department

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
Email 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 Open public recruiting
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
2020 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
2018 Year 03 Month 20 Day
Last modified on
2019 Year 09 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036335

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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