High-tech Acupuncture for Treatment of Chronic Fatigue Syndrome

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

Status and phase: Unknown; Phase 2

Conditions: Chronic Fatigue Syndrome

Treatments: Other: Acupuncture; Other: placebo; Other: moxibustion

Study type: Interventional

Funder types: Other

Identifiers

NCT02924831

XTCX2016-QXZ

Details and patient eligibility

About

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).

Enrollment: 210 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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210 participants in 5 patient groups, including a placebo group

Moxibustion group

Experimental group

Description:

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

Treatment:

Other: moxibustion

Acupuncture group

Experimental group

Description:

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

Treatment:

Other: Acupuncture

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Other: placebo

Zusanli（ST36)-acupuncture group

Experimental group

Description:

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

Treatment:

Other: Acupuncture

Guanyuan(RN4)-acupuncture group

Experimental group

Description:

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

Treatment:

Other: Acupuncture