NCT02964533

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

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 16, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Last Updated

November 16, 2016

Status Verified

November 1, 2016

Enrollment Period

3 months

First QC Date

November 12, 2016

Last Update Submit

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

EXPERIMENTAL

thunder-fire moxibustion therapy

Other: thunder-fire moxibustion therapy

MSM

ACTIVE COMPARATOR

common moxa-stick moxibustion therapy

Other: common moxa-stick moxibustion

Interventions

burn moxa stick and heat shenque acupoint

TFM

burn moxa stick and heat shenque acupoint

MSM

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

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

Fatigue Syndrome, Chronic

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesEncephalomyelitisNeuroinflammatory DiseasesNervous System DiseasesNeuromuscular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Haili Luo

    Guangdong Provincial Hospital of Traditional Chinese Medicine

    PRINCIPAL INVESTIGATOR

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

Locations