Clinical trial NCT05305872: Gandouling in the Treatment of Wilson's Disease
Official title: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Wilson's Disease
Lead sponsor: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 240
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Unified Wilson's Disease Rating Scale(UWDRS)
timeFrame: Baseline, before the study
measure: Unified Wilson's Disease Rating Scale(UWDRS)
timeFrame: 4 weeks
measure: Unified Wilson's Disease Rating Scale(UWDRS)
timeFrame: 12 weeks
measure: Unified Wilson's Disease Rating Scale(UWDRS)
timeFrame: 24 weeks
Secondary outcomes:
measure: 24-hour urinary copper
timeFrame: Baseline, before the study
measure: 24-hour urinary copper
timeFrame: 4 weeks
measure: 24-hour urinary copper
timeFrame: 12 weeks
measure: 24-hour urinary copper
timeFrame: 24 weeks
measure: non-ceruloplasmin bound copper (NCC)
timeFrame: Baseline, before the study
measure: non-ceruloplasmin bound copper (NCC)
timeFrame: 4 weeks
measure: non-ceruloplasmin bound copper (NCC)
timeFrame: 12 weeks
measure: non-ceruloplasmin bound copper (NCC)
timeFrame: 24 weeks
Other outcomes:
measure: Global Assessment Scale (GAS)
timeFrame: Baseline, before the study
measure: Global Assessment Scale (GAS)
timeFrame: 4 weeks
measure: Global Assessment Scale (GAS)
timeFrame: 12 weeks
measure: Global Assessment Scale (GAS)
timeFrame: 24 weeks
measure: Short Form-36 Questionnaire (SF-36)
timeFrame: Baseline, before the study
measure: Short Form-36 Questionnaire (SF-36)
timeFrame: 4 weeks
measure: Short Form-36 Questionnaire (SF-36)
timeFrame: 12 weeks
measure: Short Form-36 Questionnaire (SF-36)
timeFrame: 24 weeks
Locations:
city: Hefei
country: China
facility: Jun Li
state: Anhui
Study officials:
References: