UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009646 |
|---|---|
| Receipt number | R000011315 |
| Scientific Title | Effect of yoga therapy on chronic fatigue syndrome |
| Date of disclosure of the study information | 2012/12/28 |
| Last modified on | 2018/02/28 14:49:42 |
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Basic information
Public title
Effect of yoga therapy on chronic fatigue syndrome
Acronym
Yoga for chronic fatigue syndrome
Scientific Title
Effect of yoga therapy on chronic fatigue syndrome
Scientific Title:Acronym
Yoga for chronic fatigue syndrome
Region
| Japan |
Condition
Condition
chronic fatigue syndrome
Classification by specialty
| Psychosomatic Internal Medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study safety and efficacy of yoga on chronic fatigue syndrome.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Severity of fatigue
Key secondary outcomes
Other physical and psychological symptoms, autonomic functions, adverse reactions, and dosage of medication.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Conventional therapy and yoga group
Interventions/Control_2
Conventional therapy group
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Those who satisfy the diagnostic criteria of CFS (by the Ministry of Health, Labour and Welfare).
2) Those whose ages are between 20 and 70.
3) Those whose performance status is between 3 and 7.
4) Those who can fill in questionnaires.
5) Those who can practice yoga for 20 min.
Key exclusion criteria
Those whose fatigue is assumed to be caused by other physical diseases or pregnancy.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Sudo |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Psychosomatic Medicine
Zip code
Address
Maidashi 3-1-1. Higashi-ku, Fukuoka
TEL
812-8582
nobuyuki@med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takakazu Oka |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Psychosomatic Medicine
Zip code
Address
Maidashi 3-1-1. Higashi-ku, Fukuoka
TEL
812-8582
Homepage URL
oka-t@cephal.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Psychosomatic Medicine, Graduate School of Medical Sciences, Kyushu Uninversity,
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
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
YES
Study ID_1
576
Org. issuing International ID_1
Kyushu University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
九州大学病院（福岡）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
This trial demonstrated that isometric yoga together with conventional therapy was more effective in relieving fatigue than was conventional therapy alone in patients with CFS.
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
| 2012 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 28 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 27 | Day |
Last modified on
| 2018 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011315
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
