Wilson's DiseasePhase 4NCT05305872
Gandouling in the Treatment of Wilson's Disease
A Phase 4 study testing Gandouling in people with Wilson's Disease, run by Jun Li at 1 site in China.
Trial summary
To evaluate the efficacy and safety of gandouling tablet in the treatment of clinical symptoms of Wilson's diasease. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Wilson's Disease
- What is being tested?
- Gandouling
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jun Li
Hefei, Anhui, 230037
Jun Li, doctor, 18788899919, 18788899919@163.com
About this study
Official title: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
To evaluate the efficacy and safety of gandouling tablet in the treatment of clinical symptoms of Wilson's diasease.
Read the 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.
- Conditions
- Wilson's Disease
- Being tested
- Gandouling
- Medical subject headings
- Hepatolenticular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GandoulingDrug
Also called zinc gluconate
The experimental group was given gandouling tablet + zinc gluconate simulant; The course of treatment was 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Gandouling Receives: Drug: Gandouling |
| Control group | Placebo comparator | Zinc gluconate Receives: Drug: Gandouling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, before the study
Unified Wilson's Disease Rating Scale(UWDRS)
Unified Wilson's Disease Rating Scale(UWDRS). Higher scores mean a worse outcome.
Measured: 4 weeks
Unified Wilson's Disease Rating Scale(UWDRS)
Unified Wilson's Disease Rating Scale(UWDRS).Higher scores mean a worse outcome.
Measured: 12 weeks
Unified Wilson's Disease Rating Scale(UWDRS)
Unified Wilson's Disease Rating Scale(UWDRS).Higher scores mean a worse outcome.
Measured: 24 weeks
Secondary outcomes (8)
24-hour urinary copper
24-hour urinary copper.Higher scores mean a worse outcome.
Measured: Baseline, before the study
24-hour urinary copper
24-hour urinary copper.Higher scores mean a worse outcome.
Measured: 4 weeks
24-hour urinary copper
24-hour urinary copper.Higher scores mean a worse outcome.
Measured: 12 weeks
24-hour urinary copper
24-hour urinary copper.Higher scores mean a worse outcome.
Measured: 24 weeks
non-ceruloplasmin bound copper (NCC)
non-ceruloplasmin bound copper (NCC).Higher scores mean a worse outcome.
Measured: Baseline, before the study
non-ceruloplasmin bound copper (NCC)
non-ceruloplasmin bound copper (NCC).Higher scores mean a worse outcome.
Measured: 4 weeks
non-ceruloplasmin bound copper (NCC)
non-ceruloplasmin bound copper (NCC).Higher scores mean a worse outcome.
Measured: 12 weeks
non-ceruloplasmin bound copper (NCC)
non-ceruloplasmin bound copper (NCC).Higher scores mean a worse outcome.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start1 Jan 2023
- Primary completion1 Mar 2023
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wilson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jun Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jun Li, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05305872
- Sponsor's protocol ID
- GWPS
- Status last verified
- Feb 2024
- First submitted
- 24 Nov 2021
- Last updated
- 9 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ding Y, Cao K, Yang W, Hu S, Zhang J, Yang Y, Zhang X. Mapping neurological symptoms and muscle tension representations in impaired gray matter volume of Wilson disease. Front Neurol. 2025 Jun 5;16:1560848. doi: 10.3389/fneur.2025.1560848. eCollection 2025.
PubMed 40538652
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
- ClinicalTrials.gov ID
- NCT05305872
- Acronym / sponsor ID
- GWPS
- Conditions
- Wilson's Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Jun LiUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: GandoulingGandouling |
| Control group | Placebo comparator | Drug: GandoulingZinc gluconate |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GandoulingAlso: zinc gluconateThe experimental group was given gandouling tablet + zinc gluconate simulant; The course of treatment was 24 weeks. | Drug | Control group, Treatment group |
Primary outcome
Unified Wilson's Disease Rating Scale(UWDRS)
Time frame: Baseline, before the study
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)
Time frame: 4 weeks
Unified Wilson's Disease Rating Scale(UWDRS). Higher scores mean a worse outcome.
Unified Wilson's Disease Rating Scale(UWDRS)
Time frame: 12 weeks
Unified Wilson's Disease Rating Scale(UWDRS).Higher scores mean a worse outcome.
Unified Wilson's Disease Rating Scale(UWDRS)
Time frame: 24 weeks
Unified Wilson's Disease Rating Scale(UWDRS).Higher scores mean a worse outcome.
8 secondary outcomes
24-hour urinary copper
Time frame: Baseline, before the study
24-hour urinary copper
Time frame: 4 weeks
24-hour urinary copper
Time frame: 12 weeks
24-hour urinary copper
Time frame: 24 weeks
non-ceruloplasmin bound copper (NCC)
Time frame: Baseline, before the study
non-ceruloplasmin bound copper (NCC)
Time frame: 4 weeks
non-ceruloplasmin bound copper (NCC)
Time frame: 12 weeks
non-ceruloplasmin bound copper (NCC)
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Derived from this study: PubMed 40538652Ding Y, Cao K, Yang W, Hu S, Zhang J, Yang Y, Zhang X. Mapping neurological symptoms and muscle tension representations in impaired gray matter volume of Wilson disease. Front Neurol. 2025 Jun 5;16:1560848. doi: 10.3389/fneur.2025.1560848. eCollection 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gandouling in people with Wilson's Disease, run by Jun Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Li, Doctor (18788899919, 18788899919@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unified Wilson's Disease Rating Scale(UWDRS) (time frame: Baseline, before the study). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05305872, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.