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  • Status : Approved
    • First Submitted Date : 2012/08/10
    • Registered Date : 2012/08/21
    • Last Updated Date : 2013/07/10
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1. Background

Background Information
CRIS
Registration Number
KCT0000508 
Unique Protocol ID KI1205 
Public/Brief Title Acupuncture for chronic fatigue syndrome and idiopathic chronic fatigue 
Scientific Title Acupuncture for chronic fatigue syndrome and idiopathic chronic fatigue: a multi-center randomized controlled 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-92-1 
Approval Date 2012-08-10 
Institutional Review Board  
Name Institutional Review Board of Oriental Hospital of Daejeon University 
Address  
Telephone  
Data Monitoring Committee  

3. Contact Details

Contact Details Information
Contact Person for Principal Investigator / Scientific Queries  
Name Kwon-Eui Hong 
Title Doctor 
Telephone  
Affiliation Daejeon Korean Medicine Hospital of Daejeon University 
Address  
Contact Person for Public Queries
Name Kwon-Eui Hong 
Title Doctor 
Telephone  
Affiliation Daejeon Korean Medicine Hospital of Daejeon University 
Address  
Contact Person for Updating Information
Name Jung-Eun Kim 
Title K.M.D. 
Telephone  
Affiliation Korea Institute of Oriental Medicine 
Address  

4. Status

Status Information
Study Site Multi-center (Number of center : 4)
Overall Recruitment Status Completed  
Date of First Enrollment 2012-08-31 , Actual
Target Number of Participant 150
Primary Completion Date
Study Completion Date
Recruitment Status by Participating Study Site 1
Name of Study Site Daejeon Korean Medicine Hospital of Daejeon University 
Recruitment Status Completed  
Date of First Enrollment 2012-10-08 , Actual
Recruitment Status by Participating Study Site 2
Name of Study Site Dongshin University Gwangju Oriental Hospital 
Recruitment Status Completed  
Date of First Enrollment 2012-08-31 , Actual
Recruitment Status by Participating Study Site 3
Name of Study Site Semyung University Oriental Medicine Hospital  
Recruitment Status Completed  
Date of First Enrollment 2012-09-17 , Actual
Recruitment Status by Participating Study Site 4
Name of Study Site Kyung Hee University Oriental Medicine Hospital at Gangdong 
Recruitment Status Completed  
Date of First Enrollment 2012-09-07 , Actual

5. Source of Monetary / Material Support

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

6. Sponsor Organization

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

7. Study Summary

Study Summary Information
Lay Summary This study is a multi-center randomized controlled trial whose participants are patients with chronic fatigue syndrome and idiopathic chronic fatigue and a parallel design was used to compare three groups: body acupuncture group, Saam acupuncture group, and usual care group. Its purpose is to assess the effectiveness and safety of acupuncture treatment.  

8. Study Design

Study Design Information
Study Type Interventional Study 
Study Purpose Treatment    
Phase Phase3 
Intervention Model Parallel  
Blinding/Masking Open 
Allocation RCT 
Intervention Type Medical Device  
Intervention Description Treatment groups will receive acupuncture treatment 10 times for 4 weeks and control group will continue the usual care. The follow-up observation will be made in the 5th and 13th weeks after random allocation. Both treatment and control groups will be allowed to use any kind of treatment including acupuncture, moxibustion, herbal medicine, physical treatment, conventional medication, over-the-counter drugs, supplements, exercise etc. except acupuncture treatment for chronic fatigue. Educational material for explaining on chronic fatigue will be provided in all groups.  
Number of Arms
Arm 1 Arm Label Saam acupuncture group 
Target Number of Participant 50 
Arm Type Experimental 
Arm Description Treatment points: LU8, SP3, HT8, CV6, BL15 / Retaining 15 minutes 
Arm 2 Arm Label Body acupuncture group 
Target Number of Participant 50 
Arm Type Experimental 
Arm Description Treatment points: GV20, GB20, BL11, BL13, BL15, BL18, BL20, BL23 / Retaining 15 minutes 
Arm 3 Arm Label Usual care group 
Target Number of Participant 50 
Arm Type No intervention 
Arm Description Participants in the control group will not receive acupuncture treatment and continue the usual care. 

9. Subject Eligibility

Subject Eligibility Information
Condition(s) / Problem(s) * Symptoms, signs and abnormal clinical and laboratory findings, NEC
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 19 Year ~ 65 Year
Description 1. Males and females aged 19 to 65. <br />2. Those with unexplained fatigue whose symptom is continuous and repetitive for more than 6 months. <br />3. Those with no abnormal findings in BP, CBC (Hb, Hct, WBC, Glucose), biochemical examination (AST, ALT, and Creatinine), electrolyte (Na, K, Cl), TFT (TSH, FT4), pregnancy test (fertile woman), chest X-ray test, and ECG test. <br />Abnormality criteria: DBP is 90mmHg or greater (after putting subjects at rest for more than 5 minutes, DBP was measured twice at an interval of 2 minutes or longer while they were seated and the results were averaged), Hb is smaller than 13g/dL and Hct is lower than 38% in case of a male adult while Hb is greater than 11.5g/dL and Hct is 36% or lower in case of a female adult, WBC is 11,000/mm3 or greater, random plasma glucose is 200mg/dL or greater, AST is 50 IU/L or greater and ALT is 50 IU/L or greater, Creatinine is 1.5mg/dL or greater, Na is smaller than 135mmol/L or 145mol/L or greater, K is smaller than 3.5mmol/L or 5.5mmol/L or greater, Cl is smaller than 97mmol/L or 110mmol/L or greater, TSH is smaller than 0.35mIU/mL or 5.50mIU/mL or greater, FT4 is smaller than 0.89ng/dL or 1.76ng/dL or greater, urine hCG is (+), lesions of pulmonary tuberculosis other than inactive tuberculosis in chest X-ray, and arrhythmia requiring treatment, ischemic heart disease, cardiomegaly etc. in ECG. <br />4. Those whose numeric rating scale score was at least 4 for the past week during their screening visit. <br />5. Those who consented to participation in this trial and signed an informed consent statement after listening to clear explanation of this clinical trial's purpose and characteristics.  
Exclusion Criteria 1.Those who have the following causes in their past history or history of present illness that may trigger chronic fatigue. <br /> a. Organic causes : acute, chronic liver disease (hepatitis, liver cirrhosis etc.), anemia, tuberculosis, chronic lung disease, cardiovascular disease (heart failure, hypertension etc.), endocrine/metabolic disease (diabetes, thyroid gland disease, severe obesity whose BMI is 45 or greater etc.), autoimmune disease (rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis etc.), malignant tumor, infectious disease etc. <br /> b. Psycho-social causes : depression, anxiety neurosis, recent severe stress, schizophrenia, alcoholism, diet disorder (anorexia nervosa, bulimia nervosa) etc. <br />2. Those who took the following drugs for the recent two weeks: antihypertensive drugs, antidepressants, antianxiety agent, hypnotics, antihistamines etc. <br />3. Pregnant, expecting pregnant or breast-feeding women. <br />4. Those who are participating in other clinical trials. <br />5. Those who are engaged in multiple business. <br />6. Those who have experienced hypersensitivity reaction after acupuncture treatment. <br />7. Those who are inmates at group facilities such as social welfare institutions. <br />8. Those who don't consent to an informed consent statement. <br />9. Others who clinical trial conductors consider inappropriate for participating in this trial. <br />  
Healthy Volunteers

10. Outcome Measure(s)

Outcome Measure(s) Information
Type of Primary Outcome Efficacy 
Primary Outcome(s) 1 
Outcome Fatigue Severity Scale score 
Timepoint 5th weeks after random allocation 
Secondary Outcome(s) 1 
Outcome Fatigue Severity Scale score 
Timepoint 13th weeks after random allocation 
Secondary Outcome(s) 2 
Outcome Stress Response Inventory-short form score 
Timepoint 5th and 13th weeks after random allocation 
Secondary Outcome(s) 3 
Outcome Beck Depression Inventory score 
Timepoint 5th and 13th weeks after random allocation 
Secondary Outcome(s) 4 
Outcome Numeric Rating Scale score 
Timepoint 5th and 13th weeks after random allocation 
Secondary Outcome(s) 5 
Outcome EuroQol-5 Dimenstion (EQ-5D) score 
Timepoint 5th and 13th weeks after random allocation 

11. Study Results and Publication

Study Results and Publication Information
Result Registered

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

Sharing of Study Data Information
Sharing Statement Not provided at time of Registration 
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