UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009282 |
|---|---|
| Receipt number | R000010832 |
| Scientific Title | Efficacy of Royal jelly in women with premenstrual syndrome: A randomized controlled pilot study |
| Date of disclosure of the study information | 2013/01/01 |
| Last modified on | 2016/05/10 14:40:50 |
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Basic information
Public title
Efficacy of Royal jelly in women with premenstrual syndrome: A randomized controlled pilot study
Acronym
Efficacy of Royal jelly in women with premenstrual syndrome
Scientific Title
Efficacy of Royal jelly in women with premenstrual syndrome: A randomized controlled pilot study
Scientific Title:Acronym
Efficacy of Royal jelly in women with premenstrual syndrome
Region
| Japan |
Condition
Condition
PMS
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of Royal Jelly versus placebo on PMS symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Severity of PMS/PMDD
Key secondary outcomes
Severity of PMS symptoms
Salivary cortisol
Salivary amylase
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Control (placebo)
Interventions/Control_2
Royal jelly 8T/day
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
PMS symptoms (moderate to severe PMS or PMDD)
Regular menstrual cycles (25-38 days)
Key exclusion criteria
Severe complication (liver disease, kidney disease, heart disease, lung disease, blood disease, malignancy, etc.)
Asthma, food allergy
Psychiatric disease
Target sample size
72
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Takeda |
Organization
Research Institute of Traditional Asian Medicine, Kinki University
Division name
Women's health
Zip code
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 | |
| Middle name | |
| Last name | Takashi Takeda |
Organization
Research Institute of Traditional Asian Medicine, Kinki University
Division name
Women's health
Zip code
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
Research Institute of Traditional Asian Medicine, Kinki University
Institute
Department
Personal name
Funding Source
Organization
Yamada bee farm
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
近畿大学東洋医学研究所（大阪府）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | 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
| 2012 | Year | 11 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 11 | Month | 07 | Day |
Last modified on
| 2016 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010832
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
