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Acupuncture for Hwa-byung: a randomized controlled pilot trial

Status Approved

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0001732
Unique Protocol ID	KI1501
Public/Brief Title	Acupuncture for Hwa-byung
Scientific Title	Acupuncture for Hwa-byung: a randomized controlled pilot trial
Acronym
MFDS Regulated Study	No
IND/IDE Protocol
Registered at Other Registry	No
Healthcare Benefit Approval Status

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	djomc-133
Approval Date	2015-11-06
Institutional Review Board Name	Daejeon Korean Medicine Hospital of Daejeon University IRB
Institutional Review Board Address
Institutional Review Board Telephone
Data Monitoring Committee

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Jung-Hyo Cho
Title	Professor
Telephone	+82-42-229-6806
Affiliation	Daejeon Korean Medicine Hospital of Daejeon University
Address	176-9 Daeheung-ro, Jung-gu, Daejeon
Contact Person for Public Queries
Name	Jung-Hyo Cho
Title	Professor
Telephone	+82-42-229-6806
Affiliation	Daejeon Korean Medicine Hospital of Daejeon University
Address	176-9 Daeheung-ro, Jung-gu, Daejeon
Contact Person for Updating Information
Name	Jung-Eun Kim
Title	Senior Researcher
Telephone	+82-42-223-4054
Affiliation	Korea Institute of Oriental Medicine
Address	1672 Yueseongdae-ro Yuseong-gu Daejeon

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Recruiting
Date of First Enrollment	2016-01-11 Actual
Target Number of Participant	26
Primary Completion Date
Study Completion Date
Name of Study	Daejeon Korean Medicine Hospital of Daejeon University
Recruitment Status	Recruiting
Date of First Enrollment	2016-01-11 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Korea Institute of Oriental Medicine
Organization Type	Research Institute
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Korea Institute of Oriental Medicine
Organization Type	Research Institute

7. Study Summary

Study Summary Information
Lay Summary	This study is a randomized, controlled, pilot trial to determine the study feasibility of acupuncture treatment for Hwa-byung and to explore the treatment effects.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Treatment
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Single
Blinded Subject	Subject, Caregiver, Outcome Accessor
Allocation	RCT
Intervention Type	Medical Device
Intervention Description	Participants will be randomly assigned to one of two groups, receiving a typical or an atypical form of acupuncture. They will receive a total of 10 sessions over the course of 4 weeks.
Number of Arms	2
Arm 1	Arm Label Typical acupuncture group
	Target Number of Participant 13
	Arm Type Experimental
	Arm Description In the typical acupuncture group, 2 to 3 acupuncture sessions per week will be performed during a 4-week period for a total of 10 sessions. A total of 4 fixed acupoints (GV20, CV17, HT7, and ST36) and 2 individual acupoints (according to pattern identification) will be used for treatment during each 20-minute session.
Arm 2	Arm Label Atypical acupuncture group
	Target Number of Participant 13
	Arm Type Sham comparator
	Arm Description In the atypical acupuncture group, 2 to 3 acupuncture sessions per week will be performed during a 4-week period for a total of 10 sessions. A total of 5 non-acupoints (forearms, abdomen, and lower limbs) will be used for treatment during each 20-minute session.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (U00-U99)Codes for special purposes (U22.2)Repressed fire disorder
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 20Year~65Year
	Description 1. Men and women aged 20 to 65 years 2. Meeting the diagnostic criteria of the Hwa-byung Diagnostic Interview Schedule (HBDIS) 3. Providing written informed consent after being informed of the objectives and particularities of the clinical trial and agreeing to participate in the trial.
Exclusion Criteria	1. History of serious psychiatric or neurologic disorders 2. Taking drugs related to Hwa-byung, such as antidepressants, during the preceding 1 month 3. A seriously unstable medical condition 4. Participating in other clinical trials 5. Female participants who are pregnant, breast-feeding, or planning to become pregnant 6. Residents of collective dwelling facilities, such as social welfare institutions 7. Failing to provide written informed consent 8. Being considered unfit for the trial by the principal investigator for other reasons.
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	/Safety/Efficacy
Outcome	Recruitment rate
Timepoint	9 weeks after randomization
Primary Outcome(s) 2
Outcome	Adherence rate
Timepoint	9 weeks after randomization
Primary Outcome(s) 3
Outcome	Completion rate
Timepoint	9 weeks after randomization
Secondary Outcome(s) 1
Outcome	Visual Analog Scale for the core symptoms of Hwa-byung
Timepoint	3, 5, and 9 weeks after randomization
Secondary Outcome(s) 2
Outcome	Visual Analog Scale for the subjective anger
Timepoint	3, 5, and 9 weeks after randomization
Secondary Outcome(s) 3
Outcome	Beck Depression Inventory
Timepoint	3, 5, and 9 weeks after randomization
Secondary Outcome(s) 4
Outcome	A short form of Stress Response Inventory
Timepoint	3, 5, and 9 weeks after randomization
Secondary Outcome(s) 5
Outcome	Serotonin
Timepoint	5 weeks after randomization
Secondary Outcome(s) 6
Outcome	Instrument of oriental medical evaluation for Hwa-byung
Timepoint	5 weeks after randomization
Secondary Outcome(s) 7
Outcome	Adverse events
Timepoint	Every visit

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	Not provided at time of Registration