High-tech Acupuncture for Treatment of Chronic Fatigue Syndrome

NCT ID: NCT02924831

Last Updated: 2016-10-05

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

PHASE2

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2018-07-31

Brief Summary

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1. To study the relationship between Chronic Fatigue Syndrome (CFS) and heart rate (HR) and its variability (HRV).
2. To compare the curative effects and the HR/HRV indices between applicationa of different acupoints as well as different treatments (acupuncture and moxibustion).

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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Moxibustion group

drug:moxa Moxibustion was to stimulate acupoints of Guanyuan(RN4)and the Zusanli(ST36) with burned moxa.

Group Type EXPERIMENTAL

moxibustion

Intervention Type OTHER

Stimulating acupoints by using burned moxa

Acupuncture group

material: stainless steel needle In acupuncture treatment, needles were applied to acupoints of Guanyuan(RN4)and Zusanli(ST36),with manipulations to get Deqi sensation.

Group Type EXPERIMENTAL

Acupuncture

Intervention Type OTHER

Stimulating acupoints by using stainless steel needles with manual manipulation.

Placebo group

material: stainless steel needle Needles were applied to acupoints of Guanyuan(RN4)and Zusanli(ST36),but without any manipulations and Deqi sensation.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

Stimulating acupoints by using stainless steel needles without manual manipulation.

Zusanli(ST36)-acupuncture group

material: stainless steel needle Stimulating acupoints of Zusanli(ST36) with acupuncture.

Group Type EXPERIMENTAL

Acupuncture

Intervention Type OTHER

Stimulating acupoints by using stainless steel needles with manual manipulation.

Guanyuan(RN4)-acupuncture group

material: stainless steel needle. Stimulating acupoint of Guanyuan(RN4) with acupuncture.

Group Type EXPERIMENTAL

Acupuncture

Intervention Type OTHER

Stimulating acupoints by using stainless steel needles with manual manipulation.

Interventions

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Acupuncture

Stimulating acupoints by using stainless steel needles with manual manipulation.

Intervention Type OTHER

moxibustion

Stimulating acupoints by using burned moxa

Intervention Type OTHER

placebo

Stimulating acupoints by using stainless steel needles without manual manipulation.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. The patients meeting criteria of CFS;
2. Aged from 18-65;
3. With no skin lesions for the acupuncture area;
4. Sign on the Informed Consent Form;

Exclusion Criteria

1. Patients who can't accept and are afraid of acupuncture in the acupuncture group.
2. Patients suffering from heart and cerebrovascular diseases, serious lung disease, diabetes, neurological diseases, or severe primary diseases such as those of liver, kidney and the hematopoietic system.
3. Persons suffering from a mental disease, Alzheimer's disease or cancer.
4. Persons who have taken qi-reinforcing Chinese herbal medicine in the week preceding the investigation.
5. Pregnant women and nursing mothers.
6. Persons suffering from thrombocytopenia and abnormalities of blood coagulation function.
7. Persons with alcohol and drug abuse history.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hubei Provincial Collaborative Innovation Center of Preventive Treatment by Acupuncture and Moxibust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hubei university of TCM

Wuhan, Hubei, China

Site Status

Countries

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China

Central Contacts

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Liang feng xia, Doctor

Role: CONTACT

+86 18971371818

References

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Li T, Litscher G, Zhou Y, Song Y, Shu Q, Chen L, Huang Q, Wang Y, Tian H, Teng R, Wang H, Liang F. Effects of acupuncture and moxibustion on heart rate variability in chronic fatigue syndrome patients: Regulating the autonomic nervous system in a clinical randomized controlled trial. Complement Ther Med. 2025 Sep;92:103184. doi: 10.1016/j.ctim.2025.103184. Epub 2025 Apr 30.

Reference Type DERIVED
PMID: 40315935 (View on PubMed)

Other Identifiers

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XTCX2016-QXZ

Identifier Type: -

Identifier Source: org_study_id

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