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Clinical Effects on the Treatment of Metabolic Associated Fatty Liver Disease (Stagnation of dampness and heat) with Modified Zhi Shi Dao Zhi Decoction

Clinical Trial and Metabolomics Study of Modified Zhi Shi Dao Zhi Pills for the Treatment of MAFLD (Damp-Heat and Blood Stasis Pattern)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002603
Enrollment
Unknown
Registered
2025-12-30
Start date
2024-04-02
Completion date
Unknown
Last updated
2026-01-12

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

Experimental group:Lifestyle Intervention + Modified Zhi Shi Dao Zhi Decoction
Control group:Lifestyle Intervention + Xuezhikang Capsules

Sponsors

The Third Affiliated Hospital of Changchun University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Meets the diagnostic criteria for MAFLD; 2) Exhibits clear dyslipidemic indicators: elevated serum triglycerides (TG)/elevated total cholesterol (TC)/reduced HDL-C; 3) Meets the Traditional Chinese Medicine (TCM) pattern differentiation criteria for damp-heat and blood stasis obstruction syndrome; 4) Aged between 18 and 70 years; 5) Voluntarily participates in this trial after providing informed consent.

Exclusion criteria

Exclusion criteria: 1) Concurrent diabetes; 2) MAFLD has progressed to cirrhosis or hepatocellular carcinoma; 3) Liver function > 3 times the upper limit of normal, renal function > 1.5 times the upper limit of normal; 4) Concurrent other liver diseases, excluding chronic liver diseases causing fatty liver such as alcoholic liver disease, viral hepatitis, drug-induced liver injury, autoimmune hepatitis, or primary biliary cholangitis; 5) Concurrent malignant tumors, cardiovascular/cerebrovascular diseases, or severe psychiatric disorders; 6) History of allergic constitution or hypersensitivity to any investigational drug used in this trial; 7) Pregnant women, those attempting pregnancy, or lactating women; 8) Receipt of relevant therapeutic drugs within the past month. Inclusion in the trial is precluded if any of the above criteria are met.

Design outcomes

Primary

MeasureTime frame
Liver Ultrasound Imaging;waist circumference (WC);Serum total cholesterol(TC);Serum triglycerides(TG);Serum high-density lipoprotein (HDL-C);Serum Low-Density Lipoprotein (LDL);Aspartate Aminotransferase(AST);Alanine Aminotransferase(ALT);Gamma-Glutamyl Transferase;Patient reported outcomes;Traditional Chinese Medicine Syndrome Scoring;—

Countries

China

Contacts

Public ContactQu Yanan

Changchun University of Chinese Medicine

787462704@qq.com17608913389

Outcome results

None listed

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