NCT04275193Unknown2 期
The Safety and Efficacy of the Traditional Chinese Medicine Zishenqing in Subjects With Active Systemic Lupus Erythematosus
Shanghai University of Traditional Chinese Medicine1 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2019年10月22日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Lupus Quality of Life (LupusQoL)
研究概览
简要总结
This study evaluates the safety and efficacy of the traditional chinese medicine Zishenqing in the treatment of active systemic lupus erythematosus.
详细描述
This study will be a multicenter, randomized, double-blind, placebo parallel controlled clinical trial with a course of 12 weeks.
- Multicenter: During the study period, it will be decided whether to increase the improvement progress of the research unit according to whether it will be difficult to join the group and the overall progress, so as to complete the clinical study on time in accordance with the research plan.
- Random scheme: In this study, a dynamic random variance minimization random scheme will be adopted. Considering the two influencing factors of SLEDAI score and complement level, the DAS for Interactive Web Response System(IWRS) will be used to calculate and distribute random numbers and dispensing drugs.
- Control drug: Placebo will be used as control in this trial.
- Blind method: The Zishenqing simulator will be prepared by double-blind design, the dosage form, appearance, size, color and smell will be consistent with the experimental drug, and the test process will be in a double-blind state.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who qualify for the diagnosis of systemic lupus erythematosus according to the American college of rheumatology's 1997 revised classification criteria for systemic lupus erythematosus;
- •For inpatient or out-patient with good compliance, sign the informed consent before the test;
- •Sledai score during screening period≤10;
- •Maintain a stable standard treatment regimen for at least 30 days before the first day (that is, the date of administration of the intervention drug). Standard treatment regimens refer to the stable use of any of the following (alone or in combination): corticosteroids, hydroxychloroquine, non-steroidal anti-inflammatory drugs, other immunosuppressants or immunomodulators (including azathioprine, mycophenolate ester, cyclophosphamide, methotrexate, leflunomide, tacrolimus, cyclosporine);
排除标准
- •Severe lupus nephritis requiring hemodialysis or high-dose glucocorticoid treatment in the last 2 months;
- •Central nervous system diseases (including epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis) caused by SLE or non-SLE in the last 2 months;
- •Patients with severe heart, liver and kidney diseases and disease history of important organs, blood and endocrine system;
- •Evaluation criteria of severity:
- •Alanine aminotransferase(ALT) and Aspartate aminotransferase(AST)≥3 times the upper limit of normal;
- •Glomerular filtration rate(GFR)<30ml/min;
- •White Blood Cell(WBC)<2.0×10^9/l;
- •Platelet(PLT)<50×10^9/l;
- •Immunodeficiency, uncontrolled infection and active or recurrent peptic ulcer;
- •Pregnant and lactating women;
- •Anaphylaxis: allergic to traditional Chinese medicine;
- •The investigator considered it inappropriate to participate in this study;
- •Participate in other clinical trials during the screening period.
研究组 & 干预措施
Zishenqing
Experimental
The original treatment and Zishenqing 1Co by mouth,twice a day for 12 weeks
干预措施: Zishenqing (Drug)
Placebo
Placebo Comparator
The original treatment and Zishenqing simulator 1Co by mouth,twice a day for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Lupus Quality of Life (LupusQoL)
时间窗: 12weeks
Self reported the quality of life in patients with systemic lupus erythematosus.LupusQoL is made up of five parts((physical health, pain, planning, emotional health, and fatigue) and has a total of 34 questions.Each question is scored0-4,yielding a total between 0 and 136.
次要结局
- The 36-item shot form health survey(SF-36)(12weeks)
- Systemic lupus erythematosus disease activity index(SLEDAI)(12weeks)
研究者
maojianchun
Professor
Shanghai University of Traditional Chinese Medicine
研究点 (1)
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