Wilson's Disease
Conditions
Brief summary
To evaluate the efficacy and safety of gandouling tablet in the treatment of clinical symptoms of Wilson's diasease.
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.
Interventions
DRUGGandouling
The experimental group was given gandouling tablet + zinc gluconate simulant; The course of treatment was 24 weeks.
Sponsors
Jun Li
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to 65 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unified Wilson's Disease Rating Scale(UWDRS) | Baseline, before the study | Unified Wilson's Disease Rating Scale(UWDRS),the minimum is 0, and the maximum value is 320. Higher scores mean a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 24-hour urinary copper | Baseline, before the study | 24-hour urinary copper.Higher scores mean a worse outcome. |
| non-ceruloplasmin bound copper (NCC) | Baseline, before the study | non-ceruloplasmin bound copper (NCC).Higher scores mean a worse outcome. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Global Assessment Scale (GAS) | Baseline, before the study | Global Assessment Scale (GAS).Higher scores mean a worse outcome. |
| Short Form-36 Questionnaire (SF-36) | Baseline, before the study | Short Form-36 Questionnaire (SF-36).Higher scores mean a worse outcome. |
Countries
China
Contacts
Primary ContactJun Li, Doctor
Outcome results
None listed