UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000006246
Receipt No. R000006792
Scientific Title Operability assessment of integrative medicine for posttraumatic residual disability
Date of disclosure of the study information 2011/09/12
Last modified on 2014/08/31

* 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
Acronym Operability assessment of integrative medicine for posttraumatic residual disability
Scientific Title Operability assessment of integrative medicine for posttraumatic residual disability
Scientific Title:Acronym Operability assessment of integrative medicine for posttraumatic residual disability
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 acupuncture and aroma massage) 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, physical distress and mental distress

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 acupancture and psychological treatment
Interventions/Control_2 aroma massage and psychological treatment
Interventions/Control_3 Yoga 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

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 three 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 24

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 Complementary and Alternative Medicine
Zip code
Address G9, 2-2, Yamadaoka, Suita Osaka, Japan
TEL 06-6879-3498
Email n-hayashi@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 Complementary and Alternative 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 Complementary and Alternative Medicine
Institute
Department

Funding Source
Organization Osaka University Graduate school of Medicine, Depertment of Complementary and Alternative 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
2011 Year 09 Month 12 Day

Related information
URL releasing protocol http://osaka-cam.jp/wp-content/uploads/20120807.pdf
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Background: Survivors from disasters often have physical and mental distress for prolonged periods. They often ask
for help of Complementary and Alternative Medicine (CAM). It was reported that people who have both physical and
mental distress are often resistant to general insurance medical care.
Methods: This intervention was performed at Osaka University Hospital for post-traumatic residual disability. Primary
outcome is persistency rate. Secondary outcomes are change of clinical score for severity of PTSD (IES-R: Impact of
Event Scale-Revised) and depression (PHQ-9: Patient Health Questionnare-9), Satisfaction for interventions, physical
and mental distress (VAS: Visual Analog Scale), etc.
Selectable intervention (acupuncture and/or aroma treatment) was performed once a week for 8 weeks.
Results: All 9 participants selected both interventions (acupuncture and aroma treatment) , and completed the
interventions. No severe adverse event was occurred. Just after intervention, both physical and mental distress were
significantly improved. Through the intervention, both physical and mental distress were not improved, especially in
PTSD like people. Through the intervention, depression scale were significantly improved.
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 Main results already published
Date of protocol fixation
2011 Year 07 Month 13 Day
Date of IRB
Anticipated trial start date
2011 Year 09 Month 12 Day
Last follow-up date
2013 Year 08 Month 01 Day
Date of closure to data entry
2013 Year 12 Month 01 Day
Date trial data considered complete
2013 Year 12 Month 01 Day
Date analysis concluded
2014 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 08 Month 29 Day
Last modified on
2014 Year 08 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006792

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.