NCT05305872招募中4 期
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Jun Li1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2023年1月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Unified Wilson's Disease Rating Scale(UWDRS)
研究概览
简要总结
To evaluate the efficacy and safety of gandouling tablet in the treatment of clinical symptoms of Wilson's diasease.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Treatment group
Experimental
Gandouling
干预措施: Gandouling (Drug)
Control group
Placebo Comparator
Zinc gluconate
干预措施: Gandouling (Drug)
结局指标
主要结局
Unified Wilson's Disease Rating Scale(UWDRS)
时间窗: 24 weeks
Unified Wilson's Disease Rating Scale(UWDRS).Higher scores mean a worse outcome.
次要结局
- 24-hour urinary copper(24 weeks)
- non-ceruloplasmin bound copper (NCC)(24 weeks)
研究者
Jun Li
associate chief physician
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
研究点 (1)
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