Using Gandouling to Treat Wilson's Disease
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
This study is testing if a new tablet called gandouling can help people with Wilson's disease feel better compared to their current treatments.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 15 Years to 65 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine Academic / other |
| Locations | 1 site (Hefei, Anhui) |
| Trial ID | NCT05305872 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of the gandouling tablet in alleviating clinical symptoms associated with Wilson's disease. Participants will undergo assessments at baseline, 4 weeks, 12 weeks, and 24 weeks to monitor various health indicators. The study aims to determine how well gandouling can improve patient outcomes compared to existing treatments. Eligible patients must meet specific diagnostic criteria and have undergone a washout period from other copper-removing medications.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 15 and older diagnosed with Wilson's disease who meet specific clinical criteria.
Not a fit: Patients with severe neurological or liver complications related to Wilson's disease may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the management of Wilson's disease symptoms for patients.
How similar studies have performed: While this approach is novel in the context of Wilson's disease, similar studies have shown promise in evaluating new treatments for chronic conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hefei, Anhui
- Jun Li — Hefei, Anhui, China (Recruiting)
Study contacts
- Study coordinator: Jun Li, Doctor
- Email: 18788899919@163.com
- Phone: 18788899919
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.