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A multicenter, randomized controlled, double-blind and double simulated clinical evaluation of gandouling tablet in the treatment of Wilson's disease

A multicenter, randomized controlled, double-blind and double simulated clinical evaluation of gandouling tablet in the treatment of patients with hepatolenticular degeneration

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100005333
Enrollment
Unknown
Registered
2021-11-26
Start date
2021-12-12
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wilson's diasease

Interventions

2:Zinc gluconate
1:Gandouling

Sponsors

The First Affiliated Hospital of Anhui University of traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 85 Years

Inclusion criteria

Inclusion criteria: (1) Comply with the diagnosis of hepatolenticular degeneration "Guidelines for Diagnosis and Treatment of Hepatolenticular Degeneration 2021"; the diagnosis of TCM syndromes complies with the syndrome of phlegm and blood stasis; Other copper-removing drugs; (3) Patients who have been treated with complexing agents for copper-removing treatment can enter the study after a 2-week washout period; (4) Age =15 years; (5) Informed consent of patients or legal representatives, And sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) 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); (2) 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); (3) moderate to severe depression, recent suicidal thoughts or behavior, Severe psychiatric symptoms (UWDRS Part III Psychiatric Symptom Score = 54 points); (4) History of epileptic seizures within 6 months; (5) Complicated with serious diseases such as brain tumors, brain trauma, blood diseases, Cardiogenic diseases, HIV, etc.; (6) Nephritis, nephrotic syndrome, or kidney disease stage 3 or more; (7) Pregnant, planned pregnancy or breastfeeding women; (8) Cognitive dysfunction MMSE=26 points; (9) Those who are currently participating in other clinical trials; (10) Cannot comply with the follow-up plan.

Design outcomes

Primary

MeasureTime frame
Unified Wilson disease rating scale;

Secondary

MeasureTime frame
Wilson disease overall evaluation scale;Quality of life score (PDQ-39);

Countries

China

Contacts

Public ContactYang Wenming
yangwm8810@126.com18905516616

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026