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Acupuncture for chronic fatigue syndrome and idiopathic chronic fatigue: a multi-center randomized controlled trial

Status Approved

First Submitted Date

2012/08/10
Registered Date

2012/08/21
Last Updated Date

2013/07/10

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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	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
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	Kwon-Eui Hong
Title	Doctor
Telephone	+82-42-229-6816
Affiliation	Daejeon Korean Medicine Hospital of Daejeon University
Address
Contact Person for Public Queries
Name	Kwon-Eui Hong
Title	Doctor
Telephone	+82-42-229-6816
Affiliation	Daejeon Korean Medicine Hospital of Daejeon University
Address
Contact Person for Updating Information
Name	Jung-Eun Kim
Title	K.M.D.
Telephone	+82-42-223-4054
Affiliation	Korea Institute of Oriental Medicine
Address

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	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
Name of Study	Daejeon Korean Medicine Hospital of Daejeon University
Recruitment Status	Completed
Date of First Enrollment	2012-10-08 ,
Recruitment Status by Participating Study Site 2
Name of Study	Dongshin University Gwangju Oriental Hospital
Recruitment Status	Completed
Date of First Enrollment	2012-08-31 ,
Recruitment Status by Participating Study Site 3
Name of Study	Semyung University Oriental Medicine Hospital
Recruitment Status	Completed
Date of First Enrollment	2012-09-17 ,
Recruitment Status by Participating Study Site 4
Name of Study	Kyung Hee University Oriental Medicine Hospital at Gangdong
Recruitment Status	Completed
Date of First Enrollment	2012-09-07 ,

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 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.

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, 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	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	3
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)	* (R00-R99)Symptoms, signs and abnormal clinical and laboratory findings, NEC (R53)Malaise and fatigue
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~65Year
	Description 1. Males and females aged 19 to 65. 2. Those with unexplained fatigue whose symptom is continuous and repetitive for more than 6 months. 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. 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. 4. Those whose numeric rating scale score was at least 4 for the past week during their screening visit. 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. 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. b. Psycho-social causes : depression, anxiety neurosis, recent severe stress, schizophrenia, alcoholism, diet disorder (anorexia nervosa, bulimia nervosa) etc. 2. Those who took the following drugs for the recent two weeks: antihypertensive drugs, antidepressants, antianxiety agent, hypnotics, antihistamines etc. 3. Pregnant, expecting pregnant or breast-feeding women. 4. Those who are participating in other clinical trials. 5. Those who are engaged in multiple business. 6. Those who have experienced hypersensitivity reaction after acupuncture treatment. 7. Those who are inmates at group facilities such as social welfare institutions. 8. Those who don't consent to an informed consent statement. 9. Others who clinical trial conductors consider inappropriate for participating in this trial.
Healthy Volunteers

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	Efficacy
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, 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

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