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A Clinical and Mechanistic Study of Tiaojian Jiaozhi Granules for the Treatment of Metabolic-Associated Fatty Liver Disease (Study II)

Liver-Regulating and Lipid-Lowering Granules for the Treatment of Metabolic-Associated Fatty Liver Disease: Clinical and Mechanistic Studies

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000313
Enrollment
Unknown
Registered
2026-02-09
Start date
2025-11-15
Completion date
Unknown
Last updated
2026-03-02

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 (MAFLD)

Interventions

Control Group:Lifestyle intervention for 8 weeks (dietary guidance/physical activity intervention)
Experimental Group:Liver-Tuning and Lipid-Lowering Granules + 8-Week Lifestyle Intervention

Sponsors

Beijing University of Chinese Medicine Dongzhimen Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Between 18 and 70 years of age; (2) Meeting the clinical diagnostic criteria for metabolic-associated fatty liver disease (MAFLD); (3) Not having used any medications that may affect liver function and lipid levels within the past two weeks prior to enrollment in the clinical trial; (4) Providing informed consent and signing the informed consent form for this study.

Exclusion criteria

Exclusion criteria: 1. Other liver diseases: such as alcoholic liver disease, viral hepatitis, drug-induced liver disease, autoimmune liver disease, etc.; 2. Patients with severe dysfunction of heart and lung, or severe diseases of the hematopoietic system, urinary system, digestive system, rheumatic immune system, or malignant tumors; 3. Pregnant women and breastfeeding females; 4. Alanine aminotransferase = 2.5 times the upper limit of normal; 5. Individuals who have undergone weight loss treatment within the past 3 months; 6. Use of drugs that may interfere with the evaluation of efficacy (e.g., glucocorticoids, hepatoprotective drugs, weight loss drugs, etc.); 7. Presence of bone and muscle diseases that hinder physical activity; 8. Allergy to components of the investigational drug; 9. Currently participating in or having participated in other clinical trials within the past 3 months.

Design outcomes

Primary

MeasureTime frame
Controlled Attenuation Parameter;Symptom Improvement Status;

Secondary

MeasureTime frame
Body Mass Index;hip circumference;waist;Alanine Aminotransferase;Aspartate aminotransferase;Glutaminase;Total Bilirubin;Unconjugated bilirubin;Total bile acids;Total Cholesterol;Triglyceride;High-density lipoprotein cholesterol;Low-density lipoprotein cholesterol;Very Low-Density Lipoprotein (VLDL);

Countries

China

Contacts

Public ContactFeng Jiang

Dongzhimen Hospital?

jiangfeng@bucm.edu.cn010-84013212

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Mar 14, 2026