ClinicalTrials.Veeva

Menu

Gandouling in the Treatment of Wilson's Disease

J

Jun Li

Status and phase

Enrolling
Phase 4

Conditions

Wilson's Disease

Treatments

Drug: Gandouling

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

To evaluate the efficacy and safety of gandouling tablet in the treatment of clinical symptoms of Wilson's diasease.

Full 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.

Enrollment

240 estimated patients

Sex

All

Ages

15 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

240 participants in 2 patient groups, including a placebo group

Treatment group
Experimental group
Description:
Gandouling
Treatment:
Drug: Gandouling
Control group
Placebo Comparator group
Description:
Zinc gluconate
Treatment:
Drug: Gandouling

Trial contacts and locations

1

Loading...

Central trial contact

Jun Li, Doctor

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems