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A Randomized Controlled Clinical Trial of Electroacupuncture for Anxiety Related to Metabolic Associated Fatty Liver Disease

A Randomized Controlled Clinical Trial of Electroacupuncture for Anxiety Related to Metabolic Associated Fatty Liver Disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000653
Enrollment
Unknown
Registered
2026-03-20
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Related to Metabolic Associated Fatty Liver Disease

Interventions

Electroacupuncture Group:Electroacupuncture
Sham acupuncture group:sham acupuncture

Sponsors

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years (inclusive), any gender; 2. Meet diagnostic criteria for MAFLD; 3. Diagnosed with MAFLD using MRI-derived proton density fat fraction (MRI-PDFF), with hepatic steatosis =5%; 4. Meet diagnostic criteria for anxiety disorder, with HAM-A scores ranging from 14 to 28; 5. If taking oral anti-anxiety medications, stable dosage must be maintained for =4 weeks; 6. No severe cognitive impairment or mental disorders, capable of understanding and completing scale assessments; 7. Patients agree to participate, have signed informed consent, and commit to all study visits, examinations, and treatments per protocol.

Exclusion criteria

Exclusion criteria: 1. Suspected hepatobiliary diseases from other causes based on history/lab tests, including but not limited to: HBV/HCV infection, alcoholic liver disease, drug-induced liver injury, autoimmune hepatitis, cirrhosis, primary sclerosing cholangitis, Wilson's disease, alpha-1 antitrypsin deficiency, hepatocellular carcinoma (or family history); 2. Clinical evidence of cirrhosis or hepatic decompensation; 3. Severe renal insufficiency defined as serum creatinine (Scr) =178µmol/L or eGFR <60ml/min; 4. Severe primary diseases in cardiovascular, urinary, or hematopoietic systems; malignancies or other severe comorbidities; 5. Type 1 diabetes or uncontrolled type 2 diabetes (HbA1c=9.5%), antidiabetic medication adjustments within 2 months prior, or history of severe hypoglycemia; 6. Thyroid disorders including hyperthyroidism, hypothyroidism, or subclinical hypothyroidism; 7. Severe mental disorders (e.g., schizophrenia, bipolar disorder) or history of suicide attempts; 8. Received systematic acupuncture treatment within past 3 months; 9. Pregnant/lactating women or women of childbearing potential refusing approved contraception during study; 10. Participation in other clinical trials within past 3 months; 11. Severe fear of acupuncture or documented allergic reactions; 12. Other conditions deemed unsuitable by investigators.

Design outcomes

Primary

MeasureTime frame
Hamilton Anxiety Scale;

Secondary

MeasureTime frame
36-Item Short Form Health Survey;Self-Rating Anxiety Scale;Liver and kidney function;blood lipids;Blood Routine;Fasting Plasma Glucose;Homeostasis Model Assessment of Insulin Resistance;Body Mass Index (BMI);FibroScan;

Countries

China

Contacts

Public ContactHuang Lingying

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

hly320@126.com13764587034

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Apr 4, 2026