Gandouling in the Treatment of Wilson's Disease

Jun Li

Status and phase: Enrolling; Phase 4

Conditions: Wilson's Disease

Treatments: Drug: Gandouling

Study type: Interventional

Funder types: Other

Identifiers

NCT05305872

GWPS

Details and patient eligibility

About

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

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 15 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 2 patient groups, including a placebo group

Treatment group

Experimental group

Description:

Gandouling

Treatment:

Drug: Gandouling

Control group

Placebo Comparator group

Description:

Zinc gluconate

Treatment:

Drug: Gandouling