A multicenter, randomized controlled, double-blind and double simulated clinical evaluation of gandouling tablet in the treatment of Wilson's disease

Phase 1

• Conditions: Wilson's diasease

• Registration Number: ITMCTR2100005333
• Lead Sponsor: The First Affiliated Hospital of Anhui University of traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1) Comply with the diagnosis of hepatolenticular degeneration Guidelines for Diagnosis and Treatment of Hepatolenticular Degeneration 2021; the diagnosis of TCM syndromes complies with the syndrome of phlegm and blood stasis; Other copper-removing drugs; (3) Patients who have been treated with complexing agents for copper-removing treatment can enter the study after a 2-week washout period; (4) Age =15 years; (5) Informed consent of patients or legal representatives, And sign the informed consent form.

Exclusion Criteria

(1) 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); (2) 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); (3) moderate to severe depression, recent suicidal thoughts or behavior, Severe psychiatric symptoms (UWDRS Part III Psychiatric Symptom Score = 54 points); (4) History of epileptic seizures within 6 months; (5) Complicated with serious diseases such as brain tumors, brain trauma, blood diseases, Cardiogenic diseases, HIV, etc.; (6) Nephritis, nephrotic syndrome, or kidney disease stage 3 or more; (7) Pregnant, planned pregnancy or breastfeeding women; (8) Cognitive dysfunction MMSE=26 points; (9) Those who are currently participating in other clinical trials; (10) Cannot comply with the follow-up plan.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
nified Wilson disease rating scale;

Secondary Outcome Measures

Name	Time	Method
Wilson disease overall evaluation scale;Quality of life score (PDQ-39);