UMIN-CTR Clinical Trial

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

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

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

Primary outcomes

The Impact of Event Scale-revised (IESR), Japanese edition

Key secondary outcomes

serum K concentration, transaminases, Qi stagnation score

Study type

Interventional

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

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

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

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

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

Institute

Center for Traditional Asian Medicine, Nishitaga National Hospital

Institute

Department

Personal name

Organization

Nishitaga National Hospital

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

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

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

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

Date of disclosure of the study information

2013

Year

06

Month

06

Day

URL releasing protocol

http://www.hindawi.com/journals/ecam/2014/683293/

Publication of results

Published

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

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 related information

Registered date

2013

Year

06

Month

06

Day

Last modified on

2014

Year

10

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009682