Status:
RECRUITING
Gandouling in the Treatment of Wilson's Disease
Lead Sponsor:
Jun Li
Conditions:
Wilson's Disease
Eligibility:
All Genders
15-65 years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT05305872
Start Date
January 1 2023
End Date
December 31 2024
Last Update
February 9 2024
Active Locations (1)
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1
Jun Li
Hefei, Anhui, China, 230037