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Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000013746
Receipt No. R000016030
Scientific Title Effects study of yoga therapy on the association of mental illness with metabolic disorders, including the carbonyl stress
Date of disclosure of the study information 2014/05/30
Last modified on 2014/05/16

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Basic information
Public title Effects study of yoga therapy on the association of mental illness with metabolic disorders, including the carbonyl stress
Acronym Effects study of yoga therapy on the association of mental illness with metabolic disorders, including the carbonyl stress
Scientific Title Effects study of yoga therapy on the association of mental illness with metabolic disorders, including the carbonyl stress
Scientific Title:Acronym Effects study of yoga therapy on the association of mental illness with metabolic disorders, including the carbonyl stress
Region
Japan

Condition
Condition Schizophrenia
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Effects judgment of yoga therapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Oxidative-stress markers
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 yoga therapy
Interventions/Control_2 A simple exercise
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 1. Male and Female who are between 18 and 65 years of age and were diagnosed as schizophrenia according to DSM-IV.
2. Patients with consent capacity
Key exclusion criteria 1.Patients with diabetes
2.Patients with renal failure
3.Patients with Pervasive Developmental Disorders
4.Patients with Mental Retardation
Target sample size 60

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Masanari Itokawa
Organization Tokyo Metropolitan Matsuzawa
Hospital
Division name Dep.of Psychiatry
Zip code
Address 2-1-1Kamikitazawa,Setagaya-ku, Tokyo,Japan
TEL 81-3-3303-7211
Email Itokawa-ms@igakuken.or.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Hiromi Idozawa
Organization Tokyo Metropolitan Matsuzawa Hospital
Division name Department of Medicine
Zip code
Address 2-1-1Kamikitazawa,Setagaya-ku, Tokyo,Japan
TEL 81-3-3303-7211
Homepage URL http://www.byouin.metro.tokyo.jp/matsuzawa/
Email Chiken-psy@tmhp.jp

Sponsor
Institute Tokyo Metropolitan Matsuzawa
Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Tokyo Metropolitan Institute of Medical Science
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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 都立松沢病院(東京都)

Other administrative information
Date of disclosure of the study information
2014 Year 05 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 Preinitiation
Date of protocol fixation
2014 Year 04 Month 30 Day
Date of IRB
Anticipated trial start date
2014 Year 05 Month 12 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
2014 Year 04 Month 17 Day
Last modified on
2014 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016030


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