UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033874 |
|---|---|
| Receipt number | R000038633 |
| Scientific Title | Effect of yoga for female athlete with premenstrual syndrome. |
| Date of disclosure of the study information | 2018/08/30 |
| Last modified on | 2018/08/30 15:31:41 |
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Basic information
Public title
Effect of yoga for female athlete with premenstrual syndrome.
Acronym
Effect of yoga for female athlete with premenstrual syndrome.
Scientific Title
Effect of yoga for female athlete with premenstrual syndrome.
Scientific Title:Acronym
Effect of yoga for female athlete with premenstrual syndrome.
Region
| Japan |
Condition
Condition
premenstrual syndrome
Classification by specialty
| Obstetrics and Gynecology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to examine the effect of yoga on symptoms of premenstrual syndrome.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Subjective
POMS test
VAS
Objective
Serum
Estradiol
Progesterone
Cortisol
Saliva
SIgA
Autonomic nerves
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Yoga by instructor 60 minutes
Interventions/Control_2
Static stretch by instructor for 60 minutes.
Interventions/Control_3
Rest for 60minutes.(Reading books)
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
| 24 | years-old | >= |
Gender
Female
Key inclusion criteria
A person with a higher score in the luteal phase than in the follicular phase in MDQ (attendant symptom questionnaires). = Persons who have PMS symptoms.
Key exclusion criteria
Taking low dose pills
Have gynecological diseases
Yoga expert
Irregular menstrual cycle
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | HIROSE NORIKAZU |
Organization
WASEDA university
Division name
Faculty of Sports Sciences
Zip code
Address
3-4-1 Higashisakami, Nishitokyo-shi, Tokyo
TEL
042-451-1011
toitsu_hirose@waseda
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | FUKUCHI MOMOKO |
Organization
WASEDA university
Division name
Graduate School of Sport Sciences
Zip code
Address
2-7-5 Higashisakami, Nishitokyo-shi, Tokyo
TEL
090-7267-1755
Homepage URL
fukumomo0629@moegi.waseda.jp
Sponsor or person
Institute
WASEDA university
Graduate School of Sport Sciences
Institute
Department
Personal name
Funding Source
Organization
WASEDA university
Graduate School of Sport Sciences
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | Month | 30 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 08 | Month | 23 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 23 | Day |
Last modified on
| 2018 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038633
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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