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Clinical study on the treatment of metabolism-related fatty liver disease with Chinese medicine

Clinical study on the treatment of metabolism-related fatty liver disease with Chinese medicine

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074138
Enrollment
Unknown
Registered
2023-07-31
Start date
2023-08-01
Completion date
Unknown
Last updated
2023-08-07

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

Conditions

metabolic associated fatty liver disease

Interventions

Acupuncture Point Embedding Intervention Group:Acupoint embedding + diet and exercise intervention
Acupuncture point burial control group:Acupoint false embedding + diet and exercise intervention
Shenge granule treatment group:Shenge Granules+ diet and exercise intervention
Shenge granule control group:Shenge Granules placebo + diet and exercise intervention

Sponsors

Shuguang Hospital affiliated with Shanghai University of TCM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Meets diagnostic criteria for MAFLD. 2) ALT is less than 3 times the upper limit of normal. 3) Be between the ages of 18 and 65 years old, regardless of gender. 4) Not taking medication related to MAFLD treatment. 5) Sign the informed consent form.

Exclusion criteria

Exclusion criteria: Compliance with one of the following is excluded. 1) Other acute or chronic liver diseases. 2) Patients with serious primary diseases of the heart, brain, kidney and hematopoietic system. 3) Patients with acute fatty liver of pregnancy, lipid deposition disease, focal fatty liver, hepatic fatty tumors, etc. 4) Patients with mental illness. 5) Women who are pregnant or preparing for pregnancy, and breastfeeding women. 6) Unstable weight (>5% change in the previous 3 months). 7) Patients with diabetes mellitus who are being treated with insulin or oral hypoglycemic agents; 8) Current use of medications (e.g., weight-loss medications, etc.) that may interfere with the action, absorption, or disposition of the study treatment, or clinical studies. 9) Contraindications to MRI (pacemakers, Klaus phobia, implanted medical devices with ferromagnetic properties). 10) Patients with allergic idiosyncrasies. 11) Those who are unable to follow the treatment protocol to the letter. 12) Patients with prior or planned bariatric surgery during the study period. 13) Participation in an investigational new drug clinical study within 30 days prior to randomization. 14) Any other condition that, in the opinion of the investigator, may impede compliance, prevent completion of the study, jeopardize the health of the subject, or interfere with study outcomes.

Design outcomes

Primary

MeasureTime frame
MRI determination of proton density and fat content;

Secondary

MeasureTime frame
Instantaneous elastic hardness test of liver;Alanine aminotransferase;Aspartate aminotransferase;Gamma glutamyl transpeptidase;Alkaline phosphatase;Total bilirubin;Total cholesterol;Triglyceride;Free fatty acid;High-density lipoprotein cholesterol;Low-density lipoprotein cholesterol;Body mass index;Waist-to-hip ratio;Insulin Resistance Index;

Countries

China

Contacts

Public ContactSun Xuehua

Shuguang Hospital affiliated to Shanghai Universtiy of Traditonal Chinese Medicine

susan_sxh@sina.com+86 135 8576 9286

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026