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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Gandouling |
|
| Control group | Placebo Comparator | Zinc gluconate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gandouling | Drug | The experimental group was given gandouling tablet + zinc gluconate simulant; The course of treatment was 24 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour urinary copper | 24-hour urinary copper.Higher scores mean a worse outcome. | Baseline, before the study |
| 24-hour urinary copper | 24-hour urinary copper.Higher scores mean a worse outcome. |
| Measure | Description | Time Frame |
|---|---|---|
| Global Assessment Scale (GAS) | Global Assessment Scale (GAS).Higher scores mean a worse outcome. | Baseline, before the study |
| Global Assessment Scale (GAS) | Global Assessment Scale (GAS).Higher scores mean a worse outcome. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Li, Doctor | Contact | 18788899919 | 18788899919@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jun Li | Recruiting | Hefei | Anhui | 230037 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40538652 | Derived | 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. |
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| ID | Term |
|---|---|
| D006527 | Hepatolenticular Degeneration |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| C030691 | gluconic acid |
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|
| 4 weeks |
| 24-hour urinary copper | 24-hour urinary copper.Higher scores mean a worse outcome. | 12 weeks |
| 24-hour urinary copper | 24-hour urinary copper.Higher scores mean a worse outcome. | 24 weeks |
| non-ceruloplasmin bound copper (NCC) | non-ceruloplasmin bound copper (NCC).Higher scores mean a worse outcome. | Baseline, before the study |
| non-ceruloplasmin bound copper (NCC) | non-ceruloplasmin bound copper (NCC).Higher scores mean a worse outcome. | 4 weeks |
| non-ceruloplasmin bound copper (NCC) | non-ceruloplasmin bound copper (NCC).Higher scores mean a worse outcome. | 12 weeks |
| non-ceruloplasmin bound copper (NCC) | non-ceruloplasmin bound copper (NCC).Higher scores mean a worse outcome. | 24 weeks |
| 4 weeks |
| Global Assessment Scale (GAS) | Global Assessment Scale (GAS).Higher scores mean a worse outcome. | 12 weeks |
| Global Assessment Scale (GAS) | Global Assessment Scale (GAS).Higher scores mean a worse outcome. | 24 weeks |
| Short Form-36 Questionnaire (SF-36) | Short Form-36 Questionnaire (SF-36).Higher scores mean a worse outcome. | Baseline, before the study |
| Short Form-36 Questionnaire (SF-36) | Short Form-36 Questionnaire (SF-36).Higher scores mean a worse outcome. | 4 weeks |
| Short Form-36 Questionnaire (SF-36) | Short Form-36 Questionnaire (SF-36).Higher scores mean a worse outcome. | 12 weeks |
| Short Form-36 Questionnaire (SF-36) | Short Form-36 Questionnaire (SF-36).Higher scores mean a worse outcome. | 24 weeks |
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020739 | Brain Diseases, Metabolic, Inborn |
| D001928 | Brain Diseases, Metabolic |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008661 | Metabolism, Inborn Errors |
| D008664 | Metal Metabolism, Inborn Errors |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |