ITMCTR2100005333
Not yet recruiting
Phase 1
A multicenter, randomized controlled, double-blind and double simulated clinical evaluation of gandouling tablet in the treatment of patients with hepatolenticular degeneration
The First Affiliated Hospital of Anhui University of traditional Chinese Medicine0 sitesTBD
ConditionsWilson's diasease
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Wilson's diasease
- Sponsor
- The First Affiliated Hospital of Anhui University of traditional Chinese Medicine
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •(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.
Outcomes
Primary Outcomes
Not specified
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