UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Recruitment status Completed
Unique ID issued by UMIN UMIN000011601
Receipt No. R000013568
Scientific Title Operability assessment of integrative medicine for posttraumatic residual disability 2
Date of disclosure of the study information 2013/09/20
Last modified on 2016/09/14

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Operability assessment of integrative medicine for posttraumatic residual disability 2
Acronym Operability assessment of integrative medicine for posttraumatic residual disability 2
Scientific Title Operability assessment of integrative medicine for posttraumatic residual disability 2
Scientific Title:Acronym Operability assessment of integrative medicine for posttraumatic residual disability 2
Region
Japan

Condition
Condition Posttraumatic residual disability
Classification by specialty
Psychiatry Orthopedics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 First objective is operability assessment of integrated medicine (included yoga, aroma massage and thought field therapy) for patients who have posttraumatic residual disability. Second objective is Efficasy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes persistency rate in each intervention
Key secondary outcomes change of clinical score for QOL(SF36), physical distress and mental distress(Visual Analog Scale), traumatic stress(IES-R), mindfulness(MAAS), depression(PHQ-9)
Chenge of EEG and HRV

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 Factorial
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 aroma massage and psychological treatment
Interventions/Control_2 Yoga therapy and psychological treatment
Interventions/Control_3 Thought Field Therapy and psychological treatment
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria People who met accidental trauma more than one years and have residual physical distress
Key exclusion criteria People who have cognitive disorder (delirium, dementia and so on), schizophrenia or bipolar disorder.
People who need general medical treatment because of acute phase.
People who have a bad prognosis.
People who cannnot read and write Japanese.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshinori Ito
Organization Osaka University Graduate school of Medicine
Division name Depertment of Integrative Medicine
Zip code
Address G9, 2-2, Yamadaoka, Suita Osaka, Japan
TEL 06-6879-3498
Email juki@cam.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriyuki Hayashi
Organization Osaka University Graduate school of Medicine
Division name Depertment of Integrative Medicine
Zip code
Address G9, 2-2, Yamadaoka, Suita Osaka, Japan
TEL 06-6879-3498
Homepage URL
Email n-hayashi@cam.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate school of Medicine, Depertment of Integrative Medicine
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 Osaka University Graduate school of Medicine, Depertment of Integrative Medicine
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 大阪大学医学部附属病院(大阪府)

Other administrative information
Date of disclosure of the study information
2013 Year 09 Month 20 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://imj.or.jp/member/news
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 Completed
Date of protocol fixation
2013 Year 08 Month 14 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 20 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
2013 Year 08 Month 29 Day
Last modified on
2016 Year 09 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013568


Contact us.