Gandouling in the Treatment of Wilson's Disease
Phase 4
Recruiting
- Conditions
- Wilson's Disease
- Interventions
- Drug: Gandouling
- Registration Number
- NCT05305872
- Lead Sponsor
- Jun Li
- Brief Summary
To evaluate the efficacy and safety of gandouling tablet in the treatment of clinical symptoms of Wilson's diasease.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 240
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Gandouling Zinc gluconate Treatment group Gandouling Gandouling
- Primary Outcome Measures
Name Time Method Unified Wilson's Disease Rating Scale(UWDRS) 24 weeks Unified Wilson's Disease Rating Scale(UWDRS).Higher scores mean a worse outcome.
- Secondary Outcome Measures
Name Time Method 24-hour urinary copper 24 weeks 24-hour urinary copper.Higher scores mean a worse outcome.
non-ceruloplasmin bound copper (NCC) 24 weeks non-ceruloplasmin bound copper (NCC).Higher scores mean a worse outcome.
Trial Locations
- Locations (1)
Jun Li
🇨🇳Hefei, Anhui, China