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A multi-centre clinical study of Qingyun formula combined with Chinese medicine digital management intervention for MAFLD

A multi-centre clinical study of Qingyun formula combined with Chinese medicine digital management intervention for MAFLD

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000895
Enrollment
Unknown
Registered
2024-12-29
Start date
2024-07-05
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

metabolism-associated fatty liver disease

Interventions

Sponsors

Zhejiang Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18-65 years male or female; 2.Diagnosis of hepatic steatosis by imaging (including ultrasound MRI or FibroScan) or liver histology; 3.Informed and signed consent to participate in this study.

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactating women; 2. Combined with other liver diseases such as drug-induced hepatitis autoimmune liver disease alcoholic liver disease chronic hepatitis C hepatomegaly autoimmune liver disease and other liver diseases and end-stage liver disease; 3. Combined with infectious diseases such as viral hepatitis tuberculosis AIDS etc.; 4. Excessive alcohol consumption; 5. Drugs such as tamoxifen etamivir methotrexate sodium valproate and glucocorticoids and other drugs; 6. Combined with other serious systemic diseases such as coronary heart disease heart failure stroke renal insufficiency tumour serious infections etc.; 7. Major surgery or major stressful events in the past 2 months; 8. Weight fluctuation of more than 5% of one's own body weight in the past 3 months; 9. Taking drugs that cause liver injury in the past 3 months; 10. Taking drugs to treat steatohepatopathy or to correct metabolic disorders in the past 3 months. metabolic disorders.

Design outcomes

Primary

MeasureTime frame
Liver hardness value (LSM);MRI-PDFF;Control Attenuation Index (CAP);

Secondary

MeasureTime frame
lipoprotein-associated phospholipase a2;apolipoprotein B;2-hour postprandial blood glucose;glutamic-pyruvic transaminase;visceral fat mass;glutamic oxaloacetic transaminase;Low density lipoprotein cholesterol;Fasting blood glucose;total cholesterol;body fat;Bilirubin value;waist circumference;Serum free fatty acids;Changes in Traditional Chinese Medicine Syndrome Score;Apolipoprotein A;Small and dense low-density lipoprotein cholesterol;glycosylated hemoglobin;High-density lipoprotein cholesterol;Fatty liver index;Tongue image parameters;body mass index;triglyceride;non-high-density lipoprotein cholesterol;Pulse diagnosis parameters;lipoprotein;Relative changes in patient weight before and after treatment (%);

Countries

China

Contacts

Public ContactYuqun Cai

Zhejiang Provincial People's Hospital

yuqun8792@163.com+86 150 8865 8792

Outcome results

None listed

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