UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050238 |
|---|---|
| Receipt number | R000054925 |
| Scientific Title | Double-blinded randomized control study about the effects of underwear woven with blood circulation improving fibers called A.A.T.H.for the reduction of menstrual distress symptoms among sexually matured young women. |
| Date of disclosure of the study information | 2023/02/06 |
| Last modified on | 2023/02/17 11:30:37 |
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Basic information
Public title
The effects of underwear woven with blood circulation improving fibers (called A.A.T.H.) for the reduction of menstrual distress symptoms among young women.
Acronym
The effects of A.A.T.H. underwear for the reduction of menstrual distress symptoms among young women.
Scientific Title
Double-blinded randomized control study about the effects of underwear woven with blood circulation improving fibers called A.A.T.H.for the reduction of menstrual distress symptoms among sexually matured young women.
Scientific Title:Acronym
AATH effects on menstrual distress symptoms among sexually matured young women.
Region
| Japan |
Condition
Condition
Menstrual distress symtopms
Classification by specialty
| Obstetrics and Gynecology | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate if the underwear woven by blood circulation improving fibiers (called A.A.T.H) could reduce menstrul distress symptoms among sexually matured young women and eventually to contribute to increase women's QOL in thier daily life.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual Analogue Scale for pain during menstration before and after wearing the underwear
woven by A.A.T.H..
Key secondary outcomes
Menstrual Distress Questionnaire
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
| Other |
Interventions/Control_1
Wearing underwear woven with AATH fibers from one week before throughout menstration for more than 8 hours a day
Interventions/Control_2
Wearing underwear woven with ordinary fibers from one week before throughout menstration for more than 8 hours a 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
| 19 | years-old | <= |
Age-upper limit
| 25 | years-old | >= |
Gender
Female
Key inclusion criteria
1.Women aged between 19years and 25years with menstration
2.Women with BMI between 18.5 and 25
3. Women having had pain during menstration
4.Women without having OCP or LEP
5.Women without alergy against metals
Key exclusion criteria
1.Women younger than 18 and older than 26 years old
2.Women with BMI<18.5 or >25
3.Women without feeling pain during menstration
4. Women using OCP or LEP at the recruitment
5.Women with alergy against metals
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Tokiko |
| Middle name | |
| Last name | Oishi |
Organization
Takasaki University of Health and Welfare
Division name
Dept.of Nursing
Zip code
370-0033
Address
501Nakaoorui machi, Takasaki city, Gunma
TEL
027-3521291
oishi-t@takasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Tokiko |
| Middle name | |
| Last name | Oishi |
Organization
Takasaki University of Health and Welfare
Division name
Dept. of Nursing
Zip code
370-0033
Address
501Nakaoorui machi, Takasaki city, Gunma
TEL
+819050805753
Homepage URL
oishi-t@takasaki-u.ac.jp
Sponsor or person
Institute
Takasaki University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Takasaki University of Health and Welfare and Onyone cooperation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Takasaki University of Health and Welfare
Address
501Nakaoorui machi, Takasaki city, Gunma
Tel
+81273521291
kuwabara@takasaki-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
| 2023 | Year | 02 | Month | 06 | 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
129
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
| 2022 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 16 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 05 | Day |
Last modified on
| 2023 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054925
