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Clinical Trials/ITMCTR2100005333
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

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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional study
Sex
All

Investigators

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

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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