UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022430 |
|---|---|
| Receipt number | R000025666 |
| Scientific Title | The effect of the vitamins composition drug against PMS and PMDD |
| Date of disclosure of the study information | 2016/05/25 |
| Last modified on | 2017/05/25 09:46:01 |
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Basic information
Public title
The effect of the vitamins composition drug against PMS and PMDD
Acronym
The effect of the vitamins composition drug against PMS and PMDD
Scientific Title
The effect of the vitamins composition drug against PMS and PMDD
Scientific Title:Acronym
The effect of the vitamins composition drug against PMS and PMDD
Region
| Japan |
Condition
Condition
PMS/PMDD
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of pyridoxamine on PMS symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Severity of PMS/PMDD
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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, malignancy, etc.)
Psychiatric disease
Allergy for B6, B1
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | TakahiroArima |
Organization
University of Tohoku, Sendai, Japan
Division name
Innovation of New Biomedical Engineering Center
Zip code
Address
2-1 Seiryo-cho, Aoba-ku, Sendai 980-8575 Japan
TEL
022-717-7844
tarima@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | TakahiroArima |
Organization
University of Tohoku, Sendai, Japan
Division name
Innovation of New Biomedical Engineering Center
Zip code
Address
2-1 Seiryo-cho, Aoba-ku, Sendai 980-8575 Japan
TEL
022-717-7844
Homepage URL
tarima@med.tohoku.ac.jp
Sponsor or person
Institute
University of Tohoku, Sendai, Japan
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 25 | 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
| 2016 | Year | 05 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Clinical trial design: single-arm, non-randomized trials. Subject recruitment by the public offering. To target indicates the PMS symptoms of more moderate in the questionnaire to investigate the PMS symptoms.
Management information
Registered date
| 2016 | Year | 05 | Month | 24 | Day |
Last modified on
| 2017 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025666
