Status Approved
First Submitted Date
2015/12/10
Registered Date
2015/12/14
Last Updated Date
2016/11/08
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0001732 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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Overall Recruitment Status | Recruiting | |
Date of First Enrollment | 2016-01-11 Actual | |
Target Number of Participant | 26 | |
Primary Completion Date | ||
Study Completion Date | ||
Recruitment Status by Participating Study Site 1 | ||
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
1. Source of Monetary/Material Support | |
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Organization Name | Korea Institute of Oriental Medicine |
Organization Type | Research Institute |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Korea Institute of Oriental Medicine |
Organization Type | Research Institute |
7. Study Summary
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. |
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8. Study Design
Study Type | Interventional Study |
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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
Condition(s)/Problem(s) |
* (U00-U99)Codes for special purposes (U22.2)Repressed fire disorder |
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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)
Type of Primary Outcome | /Safety/Efficacy | |
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Primary Outcome(s) 1 | ||
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
Result Registered |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Not provided at time of Registration |
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