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RecruitingNCT05305872Updated Feb 9, 2024

Gandouling in the Treatment of Wilson's Disease

A Phase 4 interventional study of Gandouling in Wilson's Disease, sponsored by Jun Li. Recruiting at 1 site in China. Open to participants aged 15 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-02-09.

Sponsored by Jun Li · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2023; still recruiting 3 years 9 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
15 Years to 65 Years
Sex
All
01

Study summary

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

Read the detailed 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.

02

Conditions studied

  • Wilson's Disease
03

In context

Hepatolenticular Degeneration

78 studies on the registry are indexed under Hepatolenticular Degeneration; 30 are open to participants now.

This study's planned enrollment of 240 is above the median of 30 across 42 interventional studies indexed under Hepatolenticular Degeneration.

Browse Hepatolenticular Degeneration studies →

Lead sponsor

Jun Li is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
240 participants (estimated)

Study arms

  • Experimental
    Treatment group

    Gandouling

    Drug: Gandouling

  • Placebo comparator
    Control group

    Zinc gluconate

    Drug: Gandouling

Interventions

  • DrugGandouling

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

    Also known as: zinc gluconate

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, before the study

  2. Unified Wilson's Disease Rating Scale(UWDRS)

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

    Time frame: 4 weeks

  3. Unified Wilson's Disease Rating Scale(UWDRS)

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

    Time frame: 12 weeks

  4. Unified Wilson's Disease Rating Scale(UWDRS)

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

    Time frame: 24 weeks

Secondary outcomes

  1. 24-hour urinary copper

    24-hour urinary copper.Higher scores mean a worse outcome.

    Time frame: Baseline, before the study

  2. 24-hour urinary copper

    24-hour urinary copper.Higher scores mean a worse outcome.

    Time frame: 4 weeks

  3. 24-hour urinary copper

    24-hour urinary copper.Higher scores mean a worse outcome.

    Time frame: 12 weeks

  4. 24-hour urinary copper

    24-hour urinary copper.Higher scores mean a worse outcome.

    Time frame: 24 weeks

  5. non-ceruloplasmin bound copper (NCC)

    non-ceruloplasmin bound copper (NCC).Higher scores mean a worse outcome.

    Time frame: Baseline, before the study

  6. non-ceruloplasmin bound copper (NCC)

    non-ceruloplasmin bound copper (NCC).Higher scores mean a worse outcome.

    Time frame: 4 weeks

  7. non-ceruloplasmin bound copper (NCC)

    non-ceruloplasmin bound copper (NCC).Higher scores mean a worse outcome.

    Time frame: 12 weeks

  8. non-ceruloplasmin bound copper (NCC)

    non-ceruloplasmin bound copper (NCC).Higher scores mean a worse outcome.

    Time frame: 24 weeks

Other outcomes

  1. Global Assessment Scale (GAS)

    Global Assessment Scale (GAS).Higher scores mean a worse outcome.

    Time frame: Baseline, before the study

  2. Global Assessment Scale (GAS)

    Global Assessment Scale (GAS).Higher scores mean a worse outcome.

    Time frame: 4 weeks

  3. Global Assessment Scale (GAS)

    Global Assessment Scale (GAS).Higher scores mean a worse outcome.

    Time frame: 12 weeks

  4. Global Assessment Scale (GAS)

    Global Assessment Scale (GAS).Higher scores mean a worse outcome.

    Time frame: 24 weeks

  5. Short Form-36 Questionnaire (SF-36)

    Short Form-36 Questionnaire (SF-36).Higher scores mean a worse outcome.

    Time frame: Baseline, before the study

  6. Short Form-36 Questionnaire (SF-36)

    Short Form-36 Questionnaire (SF-36).Higher scores mean a worse outcome.

    Time frame: 4 weeks

  7. Short Form-36 Questionnaire (SF-36)

    Short Form-36 Questionnaire (SF-36).Higher scores mean a worse outcome.

    Time frame: 12 weeks

  8. Short Form-36 Questionnaire (SF-36)

    Short Form-36 Questionnaire (SF-36).Higher scores mean a worse outcome.

    Time frame: 24 weeks

07

Study locations

1 of 1 sites recruiting
  • Jun Li
    Hefei, Anhui 230037, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05305872
Lead sponsor
Jun Li
Responsible party
Jun Li (associate chief physician, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine) — Sponsor-investigator
First posted
Mar 31, 2022
Start date
Jan 1, 2023
Primary completion
Mar 1, 2023
Completion
Dec 31, 2024 (estimated)
Last update
Feb 9, 2024

Study contacts

Jun Li, Doctor
Contact
18788899919@163.com
18788899919

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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