UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010890
Receipt No. R000009682
Scientific Title Effects of Japanese herbal medicine saikokeishikankyoto (SKK) on PTSD
Date of disclosure of the study information 2013/06/06
Last modified on 2014/10/21

* 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 Effects of Japanese herbal medicine saikokeishikankyoto (SKK) on PTSD
Acronym Effects of saikokeishikankyoto (SKK) on PTSD
Scientific Title Effects of Japanese herbal medicine saikokeishikankyoto (SKK) on PTSD
Scientific Title:Acronym Effects of saikokeishikankyoto (SKK) on PTSD
Region
Japan

Condition
Condition Post Traumatic Stress Disorder (PTSD) due to the East Japan great disaster
Classification by specialty
Psychosomatic Internal Medicine Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of efficacy and safety of Japanese herbal medicine saikokeishikankyoto (SKK) for PTSD caused by East Japan great disaster.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I,II

Assessment
Primary outcomes The Impact of Event Scale-revised (IESR), Japanese edition
Key secondary outcomes serum K concentration, transaminases, Qi stagnation score

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Use of saikokeishikankyoto (SKK)
Interventions/Control_2 Waiting list
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 Adults who suffered PTSD diagnosed by DSM-IV-TR criteria after the East Japan great disaster. Only subjects with IESR over 25 points are included.
Key exclusion criteria Expectant mothers, lactating mothers, persons with chronic respiratory diseases, liver diseases, renal dysfunction, persons who regulary use stabilizers, antidepressants, antipsychotics are excluded. Persons who cannot understand the explanation of the study or cannnot consent to the study are also excluded.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koh Iwasaki
Organization Nishitaga National Hospital
Division name Center for Traditional Asian Medicine
Zip code
Address Kagitorihoncho 2-11-11, Thaihaku ward, Sendai City, Miyagi Pref. Japan
TEL -81-22-245-2111
Email iwasaki.koh67@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Koh Iwasaki
Organization Nishitaga National Hospital
Division name Center for Traditional Asian Medicine
Zip code
Address Kagitorihoncho 2-11-11, Thaihaku ward, Sendai City, Miyagi Pref. Japan
TEL -81-22-245-2111
Homepage URL http://www.hosp.go.jp/~nisitaga/index.html
Email iwasaki.koh67@gmail.com

Sponsor
Institute Center for Traditional Asian Medicine, Nishitaga National Hospital
Institute
Department

Funding Source
Organization Nishitaga National Hospital
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor 1. Department of Internal Medicine and Rehabilitation Science Tohoku University Graduate School of Medicine
2. Comprehensive education center for community medicine, Tohoku University
Name of secondary funder(s) Comprehensive education center for community medicine, Tohoku University

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 国立病院機構西多賀病院(宮城県)
Nishitaga National Hospital

Other administrative information
Date of disclosure of the study information
2013 Year 06 Month 06 Day

Related information
URL releasing protocol http://www.hindawi.com/journals/ecam/2014/683293/
Publication of results Published

Result
URL related to results and publications http://www.hindawi.com/journals/ecam/2014/683293/
Number of participants that the trial has enrolled
Results
This randomized, observer-blinded, controlled trial examined the efficacy and safety of the traditional Japanese herbal formula saikokeishikankyoto (SKK) in the treatment of PTSD among survivors of this disaster. Forty-three participants with an Impact of Event Scale-Revised (IES-R) score over 25 were randomized into SKK  and control  groups. The primary endpoint was the change in IES-R scores from baseline till after 2 weeks of treatment. Intergroup statistical comparisons were performed. The magnitude of changes in total IES-R scores differed significantly between the two groups . Post hoc analysis showed that the total IES-R score improved significantly in the SKK group from 49.6 to 25.5 (P < 0.001). Subscale scores improved significantly in the SKK group (avoidance, ; hyperarousal, ; intrusion, ). Two-week treatment with SKK significantly improved IES-R scores among PTSD patients. This traditional medicine may be a valid choice for the treatment of psychological and physical symptoms in PTSD patients.
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
2011 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 11 Month 01 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 06 Month 06 Day
Last modified on
2014 Year 10 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009682

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.