Overview

Gandouling in the Treatment of Wilson's Disease

Status:
Not yet recruiting
Trial end date:
2024-12-31
Target enrollment:
0
Participant gender:
All
Summary
To evaluate the efficacy and safety of gandouling tablet in the treatment of clinical symptoms of Wilson's diasease.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Jun Li
Criteria
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