NCT02924831

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 5, 2016

Completed
27 days until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

October 5, 2016

Status Verified

July 1, 2016

Enrollment Period

1.5 years

First QC Date

September 27, 2016

Last Update Submit

October 3, 2016

Conditions

Chronic Fatigue Syndrome

Outcome Measures

Primary Outcomes (1)

  • Chalder's Fatigue Scale Score(CFSS)

    In CFSS, symptoms of fatigue are assessed by scores ranging from 0 to 3.

    Two years

Secondary Outcomes (9)

  • Numeric Rating Scale(NRS)

    Two years

  • 36-item Short-Form Health Survey (SF-36)

    Two years

  • Deficiency of Qi Scale Score (DQSS)

    Two years

  • Total Power(TP)

    Two years

  • Low frequency(LF)

    Two years

  • +4 more secondary outcomes

Study Arms (5)

Moxibustion group

EXPERIMENTAL

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

Other: moxibustion

Acupuncture group

EXPERIMENTAL

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

Other: Acupuncture

Placebo group

PLACEBO COMPARATOR

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

Other: placebo

Zusanli（ST36)-acupuncture group

EXPERIMENTAL

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

Other: Acupuncture

Guanyuan(RN4)-acupuncture group

EXPERIMENTAL

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

Other: Acupuncture

Interventions

AcupunctureOTHER

Stimulating acupoints by using stainless steel needles with manual manipulation.

Acupuncture groupGuanyuan(RN4)-acupuncture groupZusanli（ST36)-acupuncture group
moxibustionOTHER

Stimulating acupoints by using burned moxa

Moxibustion group
placeboOTHER

Stimulating acupoints by using stainless steel needles without manual manipulation.

Placebo group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • Patients who can't accept and are afraid of acupuncture in the acupuncture group.
  • 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.
  • Persons suffering from a mental disease, Alzheimer's disease or cancer.
  • Persons who have taken qi-reinforcing Chinese herbal medicine in the week preceding the investigation.
  • Pregnant women and nursing mothers.
  • Persons suffering from thrombocytopenia and abnormalities of blood coagulation function.
  • Persons with alcohol and drug abuse history.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hubei university of TCM

Wuhan, Hubei, 430000, China

Location

Related Publications (1)

  • 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.

    PMID: 40315935DERIVED

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Interventions

Acupuncture TherapyMoxibustion

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Central Study Contacts

Liang feng xia, Doctor

CONTACT

+86 18971371818315938821@qq.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2016

First Posted

October 5, 2016

Study Start

November 1, 2016

Primary Completion

May 1, 2018

Study Completion

July 1, 2018

Last Updated

October 5, 2016

Record last verified: 2016-07

Locations

CN(1)