Gandouling in the Treatment of Wilson's Disease

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

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

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

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.

Connect with a study center

  • Jun Li

    Hefei, Anhui 230037
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.