Wilson disease
Conditions
Interventions
Study group:Gandou tablets, oral, 4 tablets, 3 times a day
Control group:Gandou tablets, oral, 4 tablets, 3 times a day
Sponsors
Hospital Affiliated to the Institute of Neurology Anhui University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria of the 2021 edition of the Chinese Guidelines for Diagnosis and Treatment of hepatolenticular degeneration; (2) In line with the TCM dialectical standard of damp-heat intrinsic syndrome; (3) During the study period except for the study drug avoid replacing the original drug; (4) Patients who had previously been treated with hepatodou tablets could enter the study after a 2-week washout period; (5) Age >=18 years; (6) The patient gives informed consent and signs the informed consent; (7) Can comply with the follow-up plan.
Exclusion criteria
Exclusion criteria: (1) Severe cerebral WD patients: significant torsion spasm dysphagia or bed rest and other severe neurological impairment will interfere with the safety of the subjects (UWDRS Part I neurological function score >=156); (2) Severe hepatic WD patients: decompensated cirrhosis or liver cancer complicated manifested by portal hypertension ascites splenomegaly (WBC=17); (3) Moderate to severe depression recent suicidal thoughts or behaviors and severe psychotic symptoms (UWDRS Part III psychiatric symptom score >=54); (4) A history of seizures within 6 months; (5) Complicated with serious diseases such as brain tumor brain trauma blood disease cardiogenic disease HIV etc. confirmed by examination; (6) nephritis nephrotic syndrome or kidney disease stage 3 or more; (7) Women who are pregnant planning pregnancy or breastfeeding; (8) Cognitive dysfunction MMSE<=26 points; (9) Those currently participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TCM syndrome integral;UWDRS score;24h urine copper;Serum biomarker; | — |
Countries
China
Contacts
Public ContactLiangliang Zhang
Hospital Affiliated to the Institute of Neurology Anhui University of Chinese Medicine
Outcome results
None listed