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Gandouling in the Treatment of Wilson's Disease

RECRUITINGPhase 4Sponsored by Jun Li
Actively Recruiting
PhasePhase 4
SponsorJun Li
Started2023-01-01
Est. completion2023-03-01
Eligibility
Age15 Years – 65 Years
Healthy vol.Accepted

Summary

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

Eligibility

Age: 15 Years – 65 YearsHealthy volunteers accepted
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

Conditions2

Liver DiseaseWilson's Disease

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