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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033874
Receipt No. 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

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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
Obsterics 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
Email 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
Email fukumomo0629@moegi.waseda.jp

Sponsor
Institute WASEDA university
Graduate School of Sport Sciences
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038633

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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