Gandouling in the Treatment of Wilson's Disease

Wilson's Disease Clinical Trial

Official title:

The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05305872
• Other study ID #: GWPS
• Status: Recruiting
• Phase: Phase 4
• Start date: January 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
• Contact: Jun Li, Doctor
• Phone: 18788899919
• Email: 18788899919[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 31, 2024
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Wilson's Disease

Intervention

Drug:
• Gandouling
The experimental group was given gandouling tablet + zinc gluconate simulant; The course of treatment was 24 weeks.

Locations

Country	Name	City	State
China	Jun Li	Hefei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Jun Li

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Global Assessment Scale (GAS)	Global Assessment Scale (GAS).Higher scores mean a worse outcome.	Baseline, before the study
Other	Global Assessment Scale (GAS)	Global Assessment Scale (GAS).Higher scores mean a worse outcome.	4 weeks
Other	Global Assessment Scale (GAS)	Global Assessment Scale (GAS).Higher scores mean a worse outcome.	12 weeks
Other	Global Assessment Scale (GAS)	Global Assessment Scale (GAS).Higher scores mean a worse outcome.	24 weeks
Other	Short Form-36 Questionnaire (SF-36)	Short Form-36 Questionnaire (SF-36).Higher scores mean a worse outcome.	Baseline, before the study
Other	Short Form-36 Questionnaire (SF-36)	Short Form-36 Questionnaire (SF-36).Higher scores mean a worse outcome.	4 weeks
Other	Short Form-36 Questionnaire (SF-36)	Short Form-36 Questionnaire (SF-36).Higher scores mean a worse outcome.	12 weeks
Other	Short Form-36 Questionnaire (SF-36)	Short Form-36 Questionnaire (SF-36).Higher scores mean a worse outcome.	24 weeks
Primary	Unified Wilson's Disease Rating Scale(UWDRS)	Unified Wilson's Disease Rating Scale(UWDRS),the minimum is 0, and the maximum value is 320. Higher scores mean a worse outcome.	Baseline, before the study
Primary	Unified Wilson's Disease Rating Scale(UWDRS)	Unified Wilson's Disease Rating Scale(UWDRS). Higher scores mean a worse outcome.	4 weeks
Primary	Unified Wilson's Disease Rating Scale(UWDRS)	Unified Wilson's Disease Rating Scale(UWDRS).Higher scores mean a worse outcome.	12 weeks
Primary	Unified Wilson's Disease Rating Scale(UWDRS)	Unified Wilson's Disease Rating Scale(UWDRS).Higher scores mean a worse outcome.	24 weeks
Secondary	24-hour urinary copper	24-hour urinary copper.Higher scores mean a worse outcome.	Baseline, before the study
Secondary	24-hour urinary copper	24-hour urinary copper.Higher scores mean a worse outcome.	4 weeks
Secondary	24-hour urinary copper	24-hour urinary copper.Higher scores mean a worse outcome.	12 weeks
Secondary	24-hour urinary copper	24-hour urinary copper.Higher scores mean a worse outcome.	24 weeks
Secondary	non-ceruloplasmin bound copper (NCC)	non-ceruloplasmin bound copper (NCC).Higher scores mean a worse outcome.	Baseline, before the study
Secondary	non-ceruloplasmin bound copper (NCC)	non-ceruloplasmin bound copper (NCC).Higher scores mean a worse outcome.	4 weeks
Secondary	non-ceruloplasmin bound copper (NCC)	non-ceruloplasmin bound copper (NCC).Higher scores mean a worse outcome.	12 weeks
Secondary	non-ceruloplasmin bound copper (NCC)	non-ceruloplasmin bound copper (NCC).Higher scores mean a worse outcome.	24 weeks