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

• Register: ChiCTR
• Last refreshed on: 17 October 2022
• Main ID: ChiCTR2100053629
• Date of registration: 2021-11-26
• Prospective Registration: Yes
• Primary sponsor: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
• Public title: A multicenter, randomized controlled, double-blind and double simulated clinical evaluation of gandouling tablet in the treatment of Wilson's disease
• Scientific title: A multicenter, randomized controlled, double-blind and double simulated clinical evaluation of gandouling tablet in the treatment of patients with hepatolenticular degeneration
• Date of first enrolment: 2021-12-12
• Target sample size: A group:100;B group:100;
• Recruitment status: Pending
• URL: http://www.chictr.org.cn/showproj.aspx?proj=139739
• Study type: Interventional study
• Study design: Parallel
• Phase: 0

Countries of recruitment

China

Contacts

• Name: Yang Wenming
• Affiliation: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

• Name: Li Jun
• Affiliation: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Key inclusion & exclusion criteria

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;
2.During the study period, avoid taking other copper repellent drugs except the drugs under study;
3.Patients who had been treated with complexing agent flooding copper in the early stage could enter the study after a 2-week elution period;
4.Aged >= 15 years;
5.Informed consent of patients or legal representatives, and sign the informed consent form;
6.Ability to follow follow-up plan.

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 * 10^9/L, PLT < 50 * 10^12/L), esophageal varices, gastrointestinal bleeding, moderate to severe anemia or hepatic encephalopathy; severe liver fibrosis shown by imaging or any laboratory abnormality (UWDRS part II 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.Patients who are currently participating in other clinical trials.


Age minimum: 15
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Wilson's disease

Intervention(s)

A group:Gandouling tablet + zinc gluconate simulator;B group:Zinc gluconate + gandouling tablet simulator;

Primary Outcome(s)

Unified Wilson disease rating scale;

Secondary Outcome(s)

Disease progression indicators;Appraisal of life quality;Constipation assessment;Blood index;Imaging index;

Secondary ID(s)

ChiMCTR2100005333

Source(s) of Monetary Support

Anhui University Collaborative Innovation Project

Ethics review

Status: Approved
Approval date: 29/10/2021
Contact:

Xu Guiqin