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Thunder-Fire Moxibustion Therapy for Chronic Fatigue Syndrome on Shenque Acupoint: a Randomized Controlled Trial

NCT ID: NCT02964533

Last Updated: 2016-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Fatigue Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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TFM

thunder-fire moxibustion therapy

Group Type EXPERIMENTAL

thunder-fire moxibustion therapy

Intervention Type OTHER

burn moxa stick and heat shenque acupoint

MSM

common moxa-stick moxibustion therapy

Group Type ACTIVE_COMPARATOR

common moxa-stick moxibustion

Intervention Type OTHER

burn moxa stick and heat shenque acupoint

Interventions

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thunder-fire moxibustion therapy

burn moxa stick and heat shenque acupoint

Intervention Type OTHER

common moxa-stick moxibustion

burn moxa stick and heat shenque acupoint

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangzhou University of Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Haili Luo

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Haili Luo

Role: PRINCIPAL_INVESTIGATOR

Guangdong Provincial Hospital of Traditional Chinese Medicine

Locations

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The Second Clinical Medical College of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Haili Luo

Role: CONTACT

Phone: 13825017002

Email: [email protected]

Facility Contacts

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haili luo

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 26939325 (View on PubMed)

Other Identifiers

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20161120

Identifier Type: -

Identifier Source: org_study_id