Back to resultsThunder-Fire Moxibustion Therapy for Chronic Fatigue Syndrome on Shenque Acupoint: a Randomized Controlled Trial
Primary Purpose
Chronic Fatigue Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
thunder-fire moxibustion therapy
common moxa-stick moxibustion
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Fatigue Syndrome
Eligibility Criteria
Inclusion Criteria:
- 1.Clinical diagnosis of chronic fatigue syndrome, 2.Age between 18 to 65 years old. 3.Must be able to accept moxibustion treatment 4.Never receive any treatment or has suspended treatment over 2 weeks 5.Patients with good adherence, signed informed consent by themselves
Exclusion Criteria:
- 1.Other primary disease caused by chronic fatigue 2.Pregnancy or breast-feeding women. 3.Merge in other serious diseases, such as severe damage in heart, liver, kidney ,lung or mental illness 4.Has took durg for insomnia treatment 5.Has received acupuncture,massage for chronic fatigue syndrome treatment 6.Suffered from infectious disease
Sites / Locations
- The Second Clinical Medical College of Guangzhou University of Chinese MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TFM
MSM
Arm Description
thunder-fire moxibustion therapy
common moxa-stick moxibustion therapy
Outcomes
Primary Outcome Measures
fatigue rating scale score
Secondary Outcome Measures
content of peripheral t-lymphocyte subsets
Full Information
NCT ID
NCT02964533
First Posted
November 12, 2016
Last Updated
November 15, 2016
Sponsor
Guangzhou University of Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02964533
Brief Title
Thunder-Fire Moxibustion Therapy for Chronic Fatigue Syndrome on Shenque Acupoint: a Randomized Controlled Trial
Official Title
Thunder-Fire Moxibustion Therapy for Chronic Fatigue Syndrome on Shenque Acupoint: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou University of Chinese Medicine
4. Oversight
5. Study Description
Brief Summary
Chronic fatigue syndrome is a group of syndrome and is prevalent in adult. Thunder-fire moxibustion is a commentary therapy belonged to acupuncture therapy. To evaluate the effect and safety of thunder-fire moxibustion therapy for chronic fatigue syndrome, we apply a randomized controlled trial by recruiting chronic fatigue syndrome patient as subject, applying thunder-fire moxibustion on shenque acupoint contrasted to common moxa-stick moxibustion, taking fatigue rating scale score, the content of CD3+、CD4+、CD8+、CD4+/CD8+ as evaluation indexes. The treatment time is 20-30 minutes per session, 3-4 times a week, there are totally 15 sessions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Fatigue Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TFM
Arm Type
Experimental
Arm Description
thunder-fire moxibustion therapy
Arm Title
MSM
Arm Type
Active Comparator
Arm Description
common moxa-stick moxibustion therapy
Intervention Type
Other
Intervention Name(s)
thunder-fire moxibustion therapy
Intervention Description
burn moxa stick and heat shenque acupoint
Intervention Type
Other
Intervention Name(s)
common moxa-stick moxibustion
Intervention Description
burn moxa stick and heat shenque acupoint
Primary Outcome Measure Information:
Title
fatigue rating scale score
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
content of peripheral t-lymphocyte subsets
Time Frame
3 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1.Clinical diagnosis of chronic fatigue syndrome, 2.Age between 18 to 65 years old. 3.Must be able to accept moxibustion treatment 4.Never receive any treatment or has suspended treatment over 2 weeks 5.Patients with good adherence, signed informed consent by themselves
Exclusion Criteria:
1.Other primary disease caused by chronic fatigue 2.Pregnancy or breast-feeding women. 3.Merge in other serious diseases, such as severe damage in heart, liver, kidney ,lung or mental illness 4.Has took durg for insomnia treatment 5.Has received acupuncture,massage for chronic fatigue syndrome treatment 6.Suffered from infectious disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haili Luo
Phone
13825017002
Email
839601539@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haili Luo
Organizational Affiliation
Guangdong Provincial Hospital of Traditional Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Clinical Medical College of Guangzhou University of Chinese Medicine
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
haili luo
Phone
13825017002
Email
839601539@qq.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
26939325
Citation
Tian L, Wang J, Luo C, Sun R, Zhang X, Yuan B, Du XZ. [Moxibustion at Gaohuang (BL 43) for chronic fatigue syndrome: a randomized controlled trial]. Zhongguo Zhen Jiu. 2015 Nov;35(11):1127-30. Chinese.
Results Reference
background
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Thunder-Fire Moxibustion Therapy for Chronic Fatigue Syndrome on Shenque Acupoint: a Randomized Controlled Trial
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