UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022677 |
|---|---|
| Receipt number | R000026135 |
| Scientific Title | Effect of occupational stressmanegment using Yoga Therapy : Pilot study |
| Date of disclosure of the study information | 2018/03/31 |
| Last modified on | 2017/03/03 13:40:09 |
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Basic information
Public title
Effect of occupational stressmanegment using Yoga Therapy : Pilot study
Acronym
Yoga Therapy study
Scientific Title
Effect of occupational stressmanegment using Yoga Therapy : Pilot study
Scientific Title:Acronym
Yoga Therapy study
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the effectiveness in reducing stress of Yoga therapy in the worke place
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Salivaly stress markers
Key secondary outcomes
Questionnaire:
POMS,SF-36,Five Facet Mindfulness Questionnaire,shitsu-taikan-sho scale
Physiological indices
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Yoga therapy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Japanese men and women,aged 20 and over
2.Employees
3.Sufficient entry formed subjects
Key exclusion criteria
1 Pregnant women
2 At the physicpatient direction
patients suffering frome
Cardian
Hypertensive disease
Diabetes
Orthopedic disease
Mental disease
Schizophrenia
Epilepsy
Depression
3 Paicets deemed inappropriate to particepate in this study by the principal investigetor
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi OHONO |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Integrative Medicine
Zip code
Address
2-2 Tamadaoka,Suita,Osaka,JAPAN
TEL
06-6879-3498
ohno@cam.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miyuki FUJII |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Integrative Medicine
Zip code
Address
2-2 Tamadaoka,Suita,Osaka,JAPAN
TEL
06-6879-3498
Homepage URL
u146050i@ecs.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Public Foundation of Kansai Research Institute
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
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
大阪大学医学部付属病院
Osaka University Hospital
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 31 | 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
| 2016 | Year | 08 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2017 | Year | 01 | 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
| 2016 | Year | 06 | Month | 09 | Day |
Last modified on
| 2017 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026135
| Research Plan | |
|---|---|
| Registered date | File name |
| 2016/12/12 | 研究計画書 ヨーガ療法.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
