- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02964533
Thunder-Fire Moxibustion Therapy for Chronic Fatigue Syndrome on Shenque Acupoint: a Randomized Controlled Trial
November 15, 2016 updated by: Haili Luo, Guangzhou University of Chinese Medicine
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: haili luo
- Phone Number: 13825017002
- Email: 839601539@qq.com
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510120
- Recruiting
- The Second Clinical Medical College of Guangzhou University of Chinese Medicine
-
Contact:
- haili luo
- Phone Number: 13825017002
- Email: 839601539@qq.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TFM
thunder-fire moxibustion therapy
|
burn moxa stick and heat shenque acupoint
|
Active Comparator: MSM
common moxa-stick moxibustion therapy
|
burn moxa stick and heat shenque acupoint
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
fatigue rating scale score
Time Frame: 5 minutes
|
5 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
content of peripheral t-lymphocyte subsets
Time Frame: 3 minutes
|
3 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Haili Luo, Guangdong Provincial Hospital of Traditional Chinese Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2016
Primary Completion (Anticipated)
February 1, 2017
Study Registration Dates
First Submitted
November 12, 2016
First Submitted That Met QC Criteria
November 15, 2016
First Posted (Estimate)
November 16, 2016
Study Record Updates
Last Update Posted (Estimate)
November 16, 2016
Last Update Submitted That Met QC Criteria
November 15, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20161120
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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