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

A multicenter, randomized controlled, double-blind and double simulated clinical evaluation of gandouling tablet in the treatment of patients with hepatolenticular degeneration

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100053629

Enrollment

Unknown

Registered

2021-11-26

Start date

2021-12-12

Completion date

Unknown

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wilson's disease

Interventions

A group:Gandouling tablet + zinc gluconate simulator

B group:Zinc gluconate + gandouling tablet simulator

Eligibility

Sex/Gender

All

Age

15 Years to No maximum

Inclusion 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

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 = 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.

Design outcomes

Primary

Measure	Time frame
Unified Wilson disease rating scale;	—

Secondary

Measure	Time frame
Disease progression indicators;Appraisal of life quality;Constipation assessment;Blood index;Imaging index;	—

Countries

China

Contacts

Public ContactYang Wenming

The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

yangwm8810@126.com+86 18905516616

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026