Chronic Fatigue Syndrome, CFS
Conditions
Interventions
Comprehensive Acupuncture-Moxibustion Regimen Group:Constitution-based Acupuncture+Comprehensive Acupuncture-Moxibustion Therapy
Basic Acupuncture Regimen Group:Constitution-based Acupuncture
Conventional Acupuncture Reference Group:Conventional Acupuncture Reference Group
Sponsors
Shenzhen Luohu District Traditional Chinese Medicine Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Main Trial (Groups A and B): Meet the diagnostic criteria for Chronic Fatigue Syndrome (CFS) revised by the U.S. Centers for Disease Control and Prevention (CDC) in 1994. Meet the TCM diagnostic criteria for "Consumptive Disease (Xu Lao)" as specified in the Guiding Principles for Clinical Research of New Chinese Medicines (Trial Implementation). Be identified as having one of the three TCM constitution types-Yang deficiency, Qi stagnation, or Damp-heat-based on the Classification and Determination of Constitution in TCM (ZYYXH/T157-2009) standard, as jointly assessed by two attending TCM physicians or above. Aged 18 to 65 years. Fatigue Severity Scale (FSS) score = 4. Voluntarily participate in the study and provide signed informed consent. Conventional Acupuncture Reference Arm (Group C): Meet the aforementioned CFS Western diagnostic criteria and TCM disease diagnostic criteria. Not belong to the Yang deficiency, Qi stagnation, or Damp-heat constitution types according to the TCM constitution standard, OR voluntarily opt out of randomization into the main trial despite meeting the constitution criteria. Aged 18 to 65 years. Fatigue Severity Scale (FSS) score = 4. Voluntarily participate in the study and provide signed informed consent.
Exclusion criteria
Exclusion criteria: Presence of other organic diseases that can explain fatigue symptoms, as evidenced by clinically significant abnormalities in screening laboratory tests (including but not limited to complete blood count, liver and kidney function, thyroid function, fasting blood glucose, etc.) that are determined to account for the fatigue. Contraindications to acupuncture or high-risk factors, including but not limited to: coagulopathy or current use of anticoagulants; severe skin infection, ulceration, or tumor at the acupuncture site; history of epilepsy or needle fainting; allergy to metal needles or moxa smoke; history of serious acupuncture adverse events such as pneumothorax or major organ injury. Pregnant, planning pregnancy, or breastfeeding women. Receipt of other systematic CFS treatments (e.g., Chinese herbal medicine, regular acupuncture, cognitive behavioral therapy) within the past 1 month. Presence of severe psychiatric disorders (e.g., schizophrenia, major depressive disorder with suicidal ideation) or cognitive impairment that precludes cooperation with treatment and assessment. Any other condition deemed unsuitable for participation in this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue Severity Scale (FSS) Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Chalder Fatigue Questionnaire (CFQ) Score;Pittsburgh Sleep Quality Index (PSQI) Score;Hospital Anxiety and Depression Scale (HADS) Score;World Health Organization Quality of Life-BREF (WHOQOL-BREF) Score; | — |
Countries
China
Contacts
Public ContactZHAI Liang
Shenzhen Luohu District Traditional Chinese Medicine Hospital (Shenzhen Hospital, Shanghai University of Traditional Chinese Medicine)
Outcome results
None listed