Gandouling in the Treatment of Wilson's Disease

NCT05305872 | Recruiting Phase 4

• 1 other identifier: GWPS
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Wilson's Disease

Outcome Measures

Primary Outcomes (4)

• 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

• Unified Wilson's Disease Rating Scale(UWDRS)

  Unified Wilson's Disease Rating Scale(UWDRS). Higher scores mean a worse outcome.

  4 weeks

• Unified Wilson's Disease Rating Scale(UWDRS)

  Unified Wilson's Disease Rating Scale(UWDRS).Higher scores mean a worse outcome.

  12 weeks

• Unified Wilson's Disease Rating Scale(UWDRS)

  Unified Wilson's Disease Rating Scale(UWDRS).Higher scores mean a worse outcome.

  24 weeks

Secondary Outcomes (8)

• 24-hour urinary copper

  Baseline, before the study

• 24-hour urinary copper

  4 weeks

• 24-hour urinary copper

  12 weeks

• 24-hour urinary copper

  24 weeks

• non-ceruloplasmin bound copper (NCC)

  Baseline, before the study

Other Outcomes (8)

• Global Assessment Scale (GAS)

  Baseline, before the study

• Global Assessment Scale (GAS)

  4 weeks

• Global Assessment Scale (GAS)

  12 weeks

Study Arms (2)

Treatment group

EXPERIMENTAL

Gandouling

Drug: Gandouling

Control group

PLACEBO COMPARATOR

Zinc gluconate

Drug: Gandouling

Interventions

Gandouling DRUG

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

Also known as: zinc gluconate

Control group; Treatment group

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jun Li: lead

Study Sites (1)

Jun Li

Hefei, Anhui, 230037, China

RECRUITING

Related Publications (1)

• Ding Y, Cao K, Yang W, Hu S, Zhang J, Yang Y, Zhang X. Mapping neurological symptoms and muscle tension representations in impaired gray matter volume of Wilson disease. Front Neurol. 2025 Jun 5;16:1560848. doi: 10.3389/fneur.2025.1560848. eCollection 2025.

  PMID: 40538652 DERIVED

MeSH Terms

Conditions

Hepatolenticular Degeneration

Interventions

gluconic acid

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolism, Inborn Errors; Metal Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Jun Li, Doctor

CONTACT

18788899919; 18788899919@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: March 31, 2022
• Study Start: January 1, 2023
• Primary Completion: March 1, 2023
• Study Completion: December 31, 2024
• Last Updated: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)