Gandouling in the Treatment of Wilson's Disease

Study Overview
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Brief Summary
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To evaluate the efficacy and safety of gandouling tablet in the treatment of clinical symptoms of Wilson's diasease.

Detailed Description
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To evaluate the efficacy and safety of gandouling tablet in the treatment of clinical symptoms of Wilson's diasease.Test various indicatorsbefore test, 4 weeks, 12 weeks and 24 weeks.

Official Title
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The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Conditions
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Wilson's Disease

Intervention / Treatment
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* Drug: Gandouling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Comply with the diagnosis of Wilson's disease Guidelines for Diagnosis and Treatment of Wilson's disease 2021 The diagnosis of TCM syndromes complies with the syndrome of phlegm and blood stasis; Other copper-removing drugs Patients who have been treated with complexing agents for copper-removing treatment can enter the study after a 2-week washout period Age ≥15 years Informed consent of patients or legal representatives, And sign the informed consent form. Exclusion Criteria: Severe cerebral WD patients: obvious 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 points) Severe liver Type WD patients: Decompensated liver cirrhosis or liver cancer, manifested as portal hypertension, ascites, splenomegaly (WBC<3.0*109/L, PLT<50*1012/L), esophageal varices, gastrointestinal bleeding, Moderate to severe anemia or hepatic encephalopathy; severe liver fibrosis shown by imaging or any laboratory abnormality (UWDRS liver function score ≥ 17 points) Moderate to severe depression, recent suicidal thoughts or behavior, Severe psychiatric symptoms (UWDRS Part III Psychiatric Symptom Score ≥ 54 points) History of epileptic seizures within 6 months Complicated with serious diseases such as brain tumors, brain trauma, blood diseases, Cardiogenic diseases, HIV, etc. Nephritis, nephrotic syndrome, or kidney disease stage 3 or more Pregnant, planned pregnancy or breastfeeding women Cognitive dysfunction MMSE≤26 points Those who are currently participating in other clinical trials Cannot comply with the follow-up plan

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Gandouling | Drug: Gandouling<br>* The experimental group was given gandouling tablet + zinc gluconate simulant; The course of treatment was 24 weeks.<br>* Other names: zinc gluconate;|
| Placebo Comparator: Control group<br>Zinc gluconate | Drug: Gandouling<br>* The experimental group was given gandouling tablet + zinc gluconate simulant; The course of treatment was 24 weeks.<br>* Other names: zinc gluconate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unified Wilson's Disease Rating Scale(UWDRS) | Unified Wilson's Disease Rating Scale(UWDRS),the minimum is 0, and the maximum value is 320. Higher scores mean a worse outcome. | Baseline, before the study | 
| Unified Wilson's Disease Rating Scale(UWDRS) | Unified Wilson's Disease Rating Scale(UWDRS). Higher scores mean a worse outcome. | 4 weeks | 
| Unified Wilson's Disease Rating Scale(UWDRS) | Unified Wilson's Disease Rating Scale(UWDRS).Higher scores mean a worse outcome. | 12 weeks | 
| Unified Wilson's Disease Rating Scale(UWDRS) | Unified Wilson's Disease Rating Scale(UWDRS).Higher scores mean a worse outcome. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour urinary copper | 24-hour urinary copper.Higher scores mean a worse outcome. | Baseline, before the study | 
| 24-hour urinary copper | 24-hour urinary copper.Higher scores mean a worse outcome. | 4 weeks | 
| 24-hour urinary copper | 24-hour urinary copper.Higher scores mean a worse outcome. | 12 weeks | 
| 24-hour urinary copper | 24-hour urinary copper.Higher scores mean a worse outcome. | 24 weeks | 
| non-ceruloplasmin bound copper (NCC) | non-ceruloplasmin bound copper (NCC).Higher scores mean a worse outcome. | Baseline, before the study | 
| non-ceruloplasmin bound copper (NCC) | non-ceruloplasmin bound copper (NCC).Higher scores mean a worse outcome. | 4 weeks | 
| non-ceruloplasmin bound copper (NCC) | non-ceruloplasmin bound copper (NCC).Higher scores mean a worse outcome. | 12 weeks | 
| non-ceruloplasmin bound copper (NCC) | non-ceruloplasmin bound copper (NCC).Higher scores mean a worse outcome. | 24 weeks |