Chronic Fatigue SyndromePhase 2NCT02924831
High-tech Acupuncture for Treatment of Chronic Fatigue Syndrome
A Phase 2 study testing Acupuncture and moxibustion in people with Chronic Fatigue Syndrome, run by Hubei Provincial Collaborative Innovation Center of Preventive Treatment by Acupuncture and Moxibust at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Fatigue Syndrome
- What is being tested?
- Acupuncture and moxibustion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to Jul 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The patients meeting criteria of CFS;
- Aged from 18-65;
- With no skin lesions for the acupuncture area;
- Sign on the Informed Consent Form;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High-tech Acupuncture for Treatment of Chronic Fatigue Syndrome - A Sino-Austrian Cooperation Randomized Controlled Trial(RCT) on Heart Rate Variability
- To study the relationship between Chronic Fatigue Syndrome (CFS) and heart rate (HR) and its variability (HRV).
- To compare the curative effects and the HR/HRV indices between applicationa of different acupoints as well as different treatments (acupuncture and moxibustion).
- Conditions
- Chronic Fatigue Syndrome
- Being tested
- Acupuncture, moxibustion, placebo
- Medical subject headings
- Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Stimulating acupoints by using stainless steel needles with manual manipulation.
moxibustionOther
Stimulating acupoints by using burned moxa
placeboOther
Stimulating acupoints by using stainless steel needles without manual manipulation.
| Study group | Role | What they receive |
|---|---|---|
| Moxibustion group | Experimental | drug:moxa Moxibustion was to stimulate acupoints of Guanyuan(RN4)and the Zusanli(ST36) with burned moxa. Receives: 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. Receives: 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. Receives: Other: placebo |
| Zusanli（ST36)-acupuncture group | Experimental | material: stainless steel needle Stimulating acupoints of Zusanli(ST36) with acupuncture. Receives: Other: Acupuncture |
| Guanyuan(RN4)-acupuncture group | Experimental | material: stainless steel needle. Stimulating acupoint of Guanyuan(RN4) with acupuncture. Receives: Other: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chalder's Fatigue Scale Score(CFSS)
In CFSS, symptoms of fatigue are assessed by scores ranging from 0 to 3.
Measured: Two years
Secondary outcomes (9)
Numeric Rating Scale(NRS)
NRC is a 10cm scale to assess the fatigue degree ranging from 0 to 10, the score of 0 stands for 'no fatigue' and 10 for 'serious'.
Measured: Two years
36-item Short-Form Health Survey (SF-36)
SF-36 consists of 36 items categorized as 8 dimensions: social functioning (2 items), role limitation-emotion (3 items), mental health (5 items), physical functioning (10 items), role limitation-physical (4 items), bodily pain (2 items), vitality (4 items), general health (5 items) and 1 question of health change in recent one year.
Measured: Two years
Deficiency of Qi Scale Score (DQSS)
In DQSS, symptoms are assessed by scores ranging from 1 to 3, which stand for 'mild' to 'serious'.
Measured: Two years
Total Power(TP)
Total Power of heart rate variability(HRV) (ms²/Hz, %)), detected by portable HRV device.
Measured: Two years
Low frequency(LF)
Low frequency band (ms²/Hz, %), detected by portable HRV device.
Measured: Two years
High frequency (HF)
High frequency band (ms²/Hz, %), detected by portable HRV device.
Measured: Two years
LF/HF
Ratio of LF and HF frequency band powers (ms²/Hz, %), calculated by LF and HF results.
Measured: Two years
Ultra-low frequency(ULF)
Ultra-low frequency band (ms²/Hz, %),detected by portable HRV device.
Measured: Two years
Very low frequency
Very low frequency band (ms²/Hz, %),,detected by portable HRV device.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionMay 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Fatigue SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hubei Provincial Collaborative Innovation Center of Preventive Treatment by Acupuncture and Moxibust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02924831
- Sponsor's protocol ID
- XTCX2016-QXZ
- Status last verified
- Jul 2016
- First submitted
- 27 Sep 2016
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 40315935
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-tech Acupuncture for Treatment of Chronic Fatigue Syndrome - A Sino-Austrian Cooperation Randomized Controlled Trial(RCT) on Heart Rate Variability
- ClinicalTrials.gov ID
- NCT02924831
- Acronym / sponsor ID
- XTCX2016-QXZ
- Conditions
- Chronic Fatigue Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Hubei Provincial Collaborative Innovation Center of Preventive Treatment by Acupuncture and MoxibustUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- May 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 5 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To study the relationship between Chronic Fatigue Syndrome (CFS) and heart rate (HR) and its variability (HRV).
- To compare the curative effects and the HR/HRV indices between applicationa of different acupoints as well as different treatments (acupuncture and moxibustion).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Moxibustion group | Experimental | Other: moxibustiondrug:moxa Moxibustion was to stimulate acupoints of Guanyuan(RN4)and the Zusanli(ST36) with burned moxa. |
| Acupuncture group | Experimental | Other: Acupuncturematerial: stainless steel needle In acupuncture treatment, needles were applied to acupoints of Guanyuan(RN4)and Zusanli(ST36),with manipulations to get Deqi sensation. |
| Placebo group | Placebo comparator | Other: placebomaterial: stainless steel needle Needles were applied to acupoints of Guanyuan(RN4)and Zusanli(ST36),but without any manipulations and Deqi sensation. |
| Zusanli（ST36)-acupuncture group | Experimental | Other: Acupuncturematerial: stainless steel needle Stimulating acupoints of Zusanli(ST36) with acupuncture. |
| Guanyuan(RN4)-acupuncture group | Experimental | Other: Acupuncturematerial: stainless steel needle. Stimulating acupoint of Guanyuan(RN4) with acupuncture. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patients meeting criteria of CFS;
- Aged from 18-65;
- With no skin lesions for the acupuncture area;
- Sign on the Informed Consent Form;
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureStimulating acupoints by using stainless steel needles with manual manipulation. | Other | Acupuncture group, Guanyuan(RN4)-acupuncture group, Zusanli（ST36)-acupuncture group |
| moxibustionStimulating acupoints by using burned moxa | Other | Moxibustion group |
| placeboStimulating acupoints by using stainless steel needles without manual manipulation. | Other | Placebo group |
Primary outcome
Chalder's Fatigue Scale Score(CFSS)
Time frame: Two years
In CFSS, symptoms of fatigue are assessed by scores ranging from 0 to 3.
9 secondary outcomes
Numeric Rating Scale(NRS)
Time frame: Two years
36-item Short-Form Health Survey (SF-36)
Time frame: Two years
Deficiency of Qi Scale Score (DQSS)
Time frame: Two years
Total Power(TP)
Time frame: Two years
Low frequency(LF)
Time frame: Two years
High frequency (HF)
Time frame: Two years
LF/HF
Time frame: Two years
Ultra-low frequency(ULF)
Time frame: Two years
Very low frequency
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2016.
- Derived from this study: PubMed 40315935Li 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acupuncture and moxibustion in people with Chronic Fatigue Syndrome, run by Hubei Provincial Collaborative Innovation Center of Preventive Treatment by Acupuncture and Moxibust at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liang feng xia, Doctor (+86 18971371818, 315938821@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chalder's Fatigue Scale Score(CFSS) (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02924831, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2016.