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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
Jun Li
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wilson's Disease

Eligibility Criteria

15 Years - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    November 24, 2021
    Last Updated
    December 11, 2022
    Sponsor
    Jun Li
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    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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