UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048151 |
|---|---|
| Receipt number | R000054871 |
| Scientific Title | The effect of chronic intake of Dioscorea esculenta powder on menstrual pain in young women-randomized crossover doubleblind study- |
| Date of disclosure of the study information | 2022/06/30 |
| Last modified on | 2022/12/23 09:35:55 |
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Basic information
Public title
The effect of chronic intake of Dioscorea esculenta powder on menstrual pain in young women
Acronym
Dioscorea esculenta intake and menstrual pain
Scientific Title
The effect of chronic intake of Dioscorea esculenta powder on menstrual pain in young women-randomized crossover doubleblind study-
Scientific Title:Acronym
The development of new supplement for prevention of severe menstrual pain
Region
| Japan |
Condition
Condition
Normal healthy adult female
Classification by specialty
| Obstetrics and Gynecology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this measurement is to investigate the effect of chronic dioscorea esculenta intake on menstrual pain and related cytokine.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
PGE2, COX-2
MPQ, DRSP
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Participants were administered Dioscorea esculenta (300 mg/day) for 4 weeks during the first trial and, after a 4-week washout period, the Dioscorea esculenta and placebo groups exchanged their assigned treatments for the second trial.
Interventions/Control_2
Participants were administered placebo for 4 weeks during the first trial and, after a 4-week washout period,the Dioscorea esculenta and placebo groups exchanged their assigned treatments for the second trial.
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
| 30 | years-old | > |
Gender
Female
Key inclusion criteria
Participants included normal menstruation about 21 days to 35 days as well as has symptoms for PMS and severe menstrual pain
Key exclusion criteria
Participants with a history of smoking, medication use, and dietary nutritional supplementation were excluded from this study
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Sato |
Organization
Kobe University
Division name
Graduate Scholl of Human Development and Environment
Zip code
657-8501
Address
3-11, Tsurukabuto, Nada-Ku, Kobe
TEL
078-803-7812
sato712@people.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Sato |
Organization
Kobe University
Division name
Graduate Scholl of Human Development and Environment
Zip code
657-8501
Address
3-11, Tsurukabuto, Nada-Ku, Kobe
TEL
078-803-7812
Homepage URL
sato712@people.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Tobe Maki Foundation
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
Kobe University
Address
3-11, Tsurukabuto, Nada-Ku, Kobe
Tel
078-803-7812
sato712@people.kobe-u.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
| 2022 | Year | 06 | Month | 30 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/36217795/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/36217795/
Number of participants that the trial has enrolled
10
Results
PGE2 and COX-2 levels significantly decreased after D. esculenta intake compared to placebo (p = 0.038, p = 0.042 each). The VAS and DRSP scores were also significantly lower after D. esculenta intake (p = 0.046, p = 0.035 each)
Results date posted
| 2022 | Year | 12 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 10 | Month | 11 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2022 | Year | 05 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 04 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 23 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 23 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 23 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 24 | Day |
Last modified on
| 2022 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054871
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
