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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040055
Receipt No. R000045666
Scientific Title Effectiveness of royl jelly for premenstrual syndrome: a randomised, double-blind, placebo-controlled trial
Date of disclosure of the study information 2020/04/04
Last modified on 2020/04/04

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Basic information
Public title Effectiveness of royl jelly for premenstrual syndrome
Acronym ERP trial
Scientific Title Effectiveness of royl jelly for premenstrual syndrome: a randomised, double-blind, placebo-controlled trial
Scientific Title:Acronym ERP double-blind, placebo-controlled trial
Region
Japan

Condition
Condition premenstrual syndrome
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To analyze the effectiveness of royl jelly supplement for premenstrual syndrome
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes DRSP total score change
Key secondary outcomes CGI-I

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 Royal jelly 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 Fulfill PMS criteria with DRSP
Key exclusion criteria Allergy to honey or honey products.
Target sample size 140

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 589-8511, 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 589-8511, Japan
TEL 072-366-0221
Homepage URL
Email take@med.kindai.ac.jp

Sponsor
Institute KIndai University
Institute
Department

Funding Source
Organization Yamada Research Grant
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kindai University Institutional Review Board
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
2020 Year 04 Month 04 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
2016 Year 12 Month 27 Day
Date of IRB
2017 Year 05 Month 02 Day
Anticipated trial start date
2017 Year 09 Month 01 Day
Last follow-up date
2021 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
2020 Year 04 Month 04 Day
Last modified on
2020 Year 04 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045666

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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