Thunder-Fire Moxibustion Therapy for Chronic Fatigue Syndrome on Shenque Acupoint: a Randomized Controlled Trial
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 12, 2016
CompletedFirst Posted
Study publicly available on registry
November 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedNovember 16, 2016
November 1, 2016
3 months
November 12, 2016
November 15, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
fatigue rating scale score
5 minutes
Secondary Outcomes (1)
content of peripheral t-lymphocyte subsets
3 minutes
Study Arms (2)
TFM
EXPERIMENTALthunder-fire moxibustion therapy
MSM
ACTIVE COMPARATORcommon moxa-stick moxibustion therapy
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Second Clinical Medical College of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, 510120, China
Related Publications (1)
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.
PMID: 26939325BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Haili Luo
Guangdong Provincial Hospital of Traditional Chinese Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
November 12, 2016
First Posted
November 16, 2016
Study Start
November 1, 2016
Primary Completion
February 1, 2017
Last Updated
November 16, 2016
Record last verified: 2016-11