To evaluate the efficacy and safety of gandouling tablet in the treatment of clinical symptoms of Wilson's diasease.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
240
The experimental group was given gandouling tablet + zinc gluconate simulant; The course of treatment was 24 weeks.
Jun Li
Hefei, Anhui, China
RECRUITINGUnified 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
Unified Wilson's Disease Rating Scale(UWDRS)
Unified Wilson's Disease Rating Scale(UWDRS). Higher scores mean a worse outcome.
Time frame: 4 weeks
Unified Wilson's Disease Rating Scale(UWDRS)
Unified Wilson's Disease Rating Scale(UWDRS).Higher scores mean a worse outcome.
Time frame: 12 weeks
Unified Wilson's Disease Rating Scale(UWDRS)
Unified Wilson's Disease Rating Scale(UWDRS).Higher scores mean a worse outcome.
Time frame: 24 weeks
24-hour urinary copper
24-hour urinary copper.Higher scores mean a worse outcome.
Time frame: Baseline, before the study
24-hour urinary copper
24-hour urinary copper.Higher scores mean a worse outcome.
Time frame: 4 weeks
24-hour urinary copper
24-hour urinary copper.Higher scores mean a worse outcome.
Time frame: 12 weeks
24-hour urinary copper
24-hour urinary copper.Higher scores mean a worse outcome.
Time frame: 24 weeks
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non-ceruloplasmin bound copper (NCC)
non-ceruloplasmin bound copper (NCC).Higher scores mean a worse outcome.
Time frame: Baseline, before the study
non-ceruloplasmin bound copper (NCC)
non-ceruloplasmin bound copper (NCC).Higher scores mean a worse outcome.
Time frame: 4 weeks
non-ceruloplasmin bound copper (NCC)
non-ceruloplasmin bound copper (NCC).Higher scores mean a worse outcome.
Time frame: 12 weeks
non-ceruloplasmin bound copper (NCC)
non-ceruloplasmin bound copper (NCC).Higher scores mean a worse outcome.
Time frame: 24 weeks