UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040055 |
|---|---|
| Receipt number | 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 | 2024/04/12 17:50:01 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
| Obstetrics 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
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
take@med.kindai.ac.jp
Sponsor or person
Institute
KIndai University
Institute
Department
Personal name
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
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
134
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
| 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
| 2022 | Year | 02 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 04 | Month | 04 | Day |
Last modified on
| 2024 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045666
