Last updated: February 8, 2024
Sponsor: Jun Li
Overall Status: Active - Recruiting
Phase
4
Condition
Liver Disorders
Liver Disease
Wilson's Disease
Treatment
Gandouling
Clinical Study ID
NCT05305872
GWPS
Ages 15-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Comply with the diagnosis of Wilson's disease "Guidelines for Diagnosis and Treatmentof 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 treatmentcan enter the study after a 2-week washout period
- Age ≥15 years
- Informed consent of patients or legal representatives, And sign the informed consentform.
Exclusion
Exclusion Criteria:
- Severe cerebral WD patients: obvious torsion spasm, dysphagia, or bed rest and othersevere neurological impairment will interfere with the safety of the subjects (UWDRSPart I neurological function score ≥156 points)
- Severe liver Type WD patients: Decompensated liver cirrhosis or liver cancer,manifested as portal hypertension, ascites, splenomegaly (WBC<3.0109/L,PLT<501012/L), esophageal varices, gastrointestinal bleeding, Moderate to severeanemia or hepatic encephalopathy; severe liver fibrosis shown by imaging or anylaboratory abnormality (UWDRS liver function score ≥ 17 points)
- Moderate to severe depression, recent suicidal thoughts or behavior, Severepsychiatric 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
Total Participants: 240
Treatment Group(s): 1
Primary Treatment: Gandouling
Phase: 4
Study Start date:
January 01, 2023
Estimated Completion Date:
December 31, 2024
Study Description
Connect with a study center
Jun Li
Hefei, Anhui 230037
ChinaActive - Recruiting
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