Gandouling in the Treatment of Wilson's Disease
Primary Purpose
Wilson's Disease
Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Gandouling
Sponsored by
About this trial
This is an interventional treatment trial for Wilson's Disease
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment group
Control group
Arm Description
Gandouling
Zinc gluconate
Outcomes
Primary Outcome Measures
Unified Wilson's Disease Rating Scale(UWDRS)
Unified Wilson's Disease Rating Scale(UWDRS),the minimum is 0, and the maximum value is 320. Higher scores mean a worse outcome.
Unified Wilson's Disease Rating Scale(UWDRS)
Unified Wilson's Disease Rating Scale(UWDRS). Higher scores mean a worse outcome.
Unified Wilson's Disease Rating Scale(UWDRS)
Unified Wilson's Disease Rating Scale(UWDRS).Higher scores mean a worse outcome.
Unified Wilson's Disease Rating Scale(UWDRS)
Unified Wilson's Disease Rating Scale(UWDRS).Higher scores mean a worse outcome.
Secondary Outcome Measures
24-hour urinary copper
24-hour urinary copper.Higher scores mean a worse outcome.
24-hour urinary copper
24-hour urinary copper.Higher scores mean a worse outcome.
24-hour urinary copper
24-hour urinary copper.Higher scores mean a worse outcome.
24-hour urinary copper
24-hour urinary copper.Higher scores mean a worse outcome.
non-ceruloplasmin bound copper (NCC)
non-ceruloplasmin bound copper (NCC).Higher scores mean a worse outcome.
non-ceruloplasmin bound copper (NCC)
non-ceruloplasmin bound copper (NCC).Higher scores mean a worse outcome.
non-ceruloplasmin bound copper (NCC)
non-ceruloplasmin bound copper (NCC).Higher scores mean a worse outcome.
non-ceruloplasmin bound copper (NCC)
non-ceruloplasmin bound copper (NCC).Higher scores mean a worse outcome.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05305872
Brief Title
Gandouling in the Treatment of Wilson's Disease
Official Title
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jun Li
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To evaluate the efficacy and safety of gandouling tablet in the treatment of clinical symptoms of Wilson's diasease.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wilson's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
216 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Gandouling
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Zinc gluconate
Intervention Type
Drug
Intervention Name(s)
Gandouling
Other Intervention Name(s)
zinc gluconate
Intervention Description
The experimental group was given gandouling tablet + zinc gluconate simulant; The course of treatment was 24 weeks.
Primary Outcome Measure Information:
Title
Unified Wilson's Disease Rating Scale(UWDRS)
Description
Unified Wilson's Disease Rating Scale(UWDRS),the minimum is 0, and the maximum value is 320. Higher scores mean a worse outcome.
Time Frame
Baseline, before the study
Title
Unified Wilson's Disease Rating Scale(UWDRS)
Description
Unified Wilson's Disease Rating Scale(UWDRS). Higher scores mean a worse outcome.
Time Frame
4 weeks
Title
Unified Wilson's Disease Rating Scale(UWDRS)
Description
Unified Wilson's Disease Rating Scale(UWDRS).Higher scores mean a worse outcome.
Time Frame
12 weeks
Title
Unified Wilson's Disease Rating Scale(UWDRS)
Description
Unified Wilson's Disease Rating Scale(UWDRS).Higher scores mean a worse outcome.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
24-hour urinary copper
Description
24-hour urinary copper.Higher scores mean a worse outcome.
Time Frame
Baseline, before the study
Title
24-hour urinary copper
Description
24-hour urinary copper.Higher scores mean a worse outcome.
Time Frame
4 weeks
Title
24-hour urinary copper
Description
24-hour urinary copper.Higher scores mean a worse outcome.
Time Frame
12 weeks
Title
24-hour urinary copper
Description
24-hour urinary copper.Higher scores mean a worse outcome.
Time Frame
24 weeks
Title
non-ceruloplasmin bound copper (NCC)
Description
non-ceruloplasmin bound copper (NCC).Higher scores mean a worse outcome.
Time Frame
Baseline, before the study
Title
non-ceruloplasmin bound copper (NCC)
Description
non-ceruloplasmin bound copper (NCC).Higher scores mean a worse outcome.
Time Frame
4 weeks
Title
non-ceruloplasmin bound copper (NCC)
Description
non-ceruloplasmin bound copper (NCC).Higher scores mean a worse outcome.
Time Frame
12 weeks
Title
non-ceruloplasmin bound copper (NCC)
Description
non-ceruloplasmin bound copper (NCC).Higher scores mean a worse outcome.
Time Frame
24 weeks
Other Pre-specified Outcome Measures:
Title
Global Assessment Scale (GAS)
Description
Global Assessment Scale (GAS).Higher scores mean a worse outcome.
Time Frame
Baseline, before the study
Title
Global Assessment Scale (GAS)
Description
Global Assessment Scale (GAS).Higher scores mean a worse outcome.
Time Frame
4 weeks
Title
Global Assessment Scale (GAS)
Description
Global Assessment Scale (GAS).Higher scores mean a worse outcome.
Time Frame
12 weeks
Title
Global Assessment Scale (GAS)
Description
Global Assessment Scale (GAS).Higher scores mean a worse outcome.
Time Frame
24 weeks
Title
Short Form-36 Questionnaire (SF-36)
Description
Short Form-36 Questionnaire (SF-36).Higher scores mean a worse outcome.
Time Frame
Baseline, before the study
Title
Short Form-36 Questionnaire (SF-36)
Description
Short Form-36 Questionnaire (SF-36).Higher scores mean a worse outcome.
Time Frame
4 weeks
Title
Short Form-36 Questionnaire (SF-36)
Description
Short Form-36 Questionnaire (SF-36).Higher scores mean a worse outcome.
Time Frame
12 weeks
Title
Short Form-36 Questionnaire (SF-36)
Description
Short Form-36 Questionnaire (SF-36).Higher scores mean a worse outcome.
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Gandouling in the Treatment of Wilson's Disease
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