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Study on the efficacy and safety of Gandou Fumu Recipe for WD with liver fibrosis

Study on the efficacy and safety of Gandou Fumu Recipe for WD with liver fibrosis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069789
Enrollment
Unknown
Registered
2023-03-26
Start date
2023-04-01
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

Wilson's disease

Interventions

treatment group:Gandou Fumu recipe + western medicine
control group:Gandou Fumu recipe Simulant + western medicine

Sponsors

The First Affiliated Hospital of Anhui University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 65 years old, gender unlimited; 2. Patients who meet the diagnostic criteria of disease; 3. Patients who meet the diagnostic criteria of liver fibrosis; 4. TCM syndrome differentiation belongs to liver and kidney deficiency, phlegm, and blood stasis syndrome; 5. Informed consent of patients or legal representatives, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with fulminant liver failure (with or without hemolytic anemia) and decompensated cirrhosis; 2. Pregnant or lactating women, or women preparing for pregnancy; 3. Concomitant with other serious diseases (such as malignant tumors, hematopoiesis, and other diseases).

Design outcomes

Primary

MeasureTime frame
liver stiffness measurement;

Secondary

MeasureTime frame
hyaluronic acid;type ? collagen;laminin;type ? procollagen peptide;Sheth index;Gaussian Process Regression (GPR) index;Fibrosis 4 (FIB-4) index;Aspartate aminotransferase-to-Platelet Ratio Index (APRI index);24-hour urine copper;uniform Wilson’s disease rating scale;traditional chinese medicine (TCM) syndrome scale;Color Doppler ultrasound of digestive system;Safety index;

Countries

China

Contacts

Public ContactWang Meixia

The First Affiliated Hospital of Anhui University of Chinese medicine

meixiawang96@sina.com+86 13856920314

Outcome results

None listed

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