研究疾病:
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类风湿性关节炎
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研究疾病代码:
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Target disease:
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Rheumatoid Arthritis
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Target disease code:
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研究类型:
Study type:
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干预性研究
Interventional study
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研究设计:
Study design:
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随机平行对照
randomized controlled trial(parallel group design)
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研究所处阶段:
Study phase:
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探索性研究/预试验
Pilot clinical trial
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研究目的:
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基于观察化瘀通痹方治疗类风湿关节炎的临床疗效, 通过前瞻性、随机、对照的临床研究试验,采用国际公认的疗效指标,通过科学严谨的方案设计和严格的质量监控,开展符合国际规范的临床研究,验证基于中药有效方药——化瘀通痹方的中西医结合方案治疗RA的疗效,并探索其可能的疗效机制,为化瘀通痹方的推广提供临床依据。
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Objectives of Study:
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Based on the observation of the clinical efficacy of Hua Yu Tong Bi Formula in the treatment of rheumatoid arthritis, we set this randomized clinical trial, using internationally recognized efficacy indicators, scientific and rigorous program design and strict quality control, to popularize the prescription and obtain the international approval. And we will study the mechanism of this formula on patients with RA further.
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药物成份或治疗方案详述:
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Description for medicine or protocol of treatment in detail:
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纳入标准:
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(1)自愿在与本研究相关的活动开始前签署知情同意书,并能够理解本研究的程序和方法,愿意严格遵守临床研究方案完成本研究;
(2)签署知情同意书时的年龄18~70周岁(包括两端值),性别不限;
(3)根据美国风湿病学会(ACR)/欧洲抗风湿病联盟(EULAR)2010年类风湿关节炎(RA)分类标准诊断为RA,筛选时ACR功能分类I~III级;
(4)轻中度疾病活动度DAS28-CRP≥2.6,≤5.1;
(5)既往未曾使用DMARDs药物治疗,或既往接受DMARD药物治疗,但至少近一个月内未使用该类药物,如既往使用LEF治疗需停药3月,既往使用生物制剂治疗需停药3月;
(6)如果受试者使用非甾体抗炎药(NSAIDs)或其他镇痛药治疗RA,必须在入组前已稳定剂量治疗至少1周。
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Inclusion criteria
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(1) Voluntarily sign the informed consent form before the start of activities related to this study, and understand the procedures and methods of the study, and be willing to strictly abide by the clinical study protocol to complete this study;
(2) The age at the time of signing the informed consent form is 18~70 years old (including both ends), and the gender is not limited;
(3) Diagnosis of RA according to the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) 2010 Rheumatoid Arthritis (RA) classification criteria, ACR functional classification grade I~III at screening;
(4) Active disease will be assessed by Disease Activity Score (DAS) 28, with DAS28-CRP ≥2.6, ≤ 5.1;
(5) Have not used DMARDs in the past, if received DMARDs before,shoud stop in the past month, such as the previous use of LEF ,needs to be discontinued for 3 months, and the previous use of biological agents needs to be discontinued for 3 months;
(6) If subjects are treated with nonsteroidal anti-inflammatory drugs (NSAIDs) or other analgesics for RA, they must have been on a stable dose for at least 1 week prior to enrollment.
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排除标准:
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(1)随机前4周内,实验室检查和12导联心电图中出现下述情况:
1)白细胞计数<3.0×109/L;
2)中性粒细胞计数<1.5×109/L;
3)血红蛋白<90.0g/L;
4)血小板计数<100×109/L;
5)丙氨酸氨基转移酶(ALT)或天门冬氨酸氨基转移酶(AST)>正常值上限1.5倍;
6)肌酐正常值上限或简化肾脏病饮食调整(MDRD)公式计算的估计的肾小球滤过率(eGFR)<60 mL/min/1.73 m²;
7)12导联心电图提示有临床意义的可能影响受试者安全的异常,包括但不限于急性心肌缺血、心肌梗死、严重心律失常或显著QTc延长(QTc>500ms);
(2)重叠其他自身免疫性疾病如原发/继发性干燥综合征、银屑病关节炎、炎症性肠病、强直性脊柱炎、系统性红斑狼疮、硬皮病或多肌炎、多发性硬化症、纤维肌痛综合征等;
(3)合并心血管、脑、肝、肺、肾和造血系统等重要器官的严重疾病,且其治疗用药影响本研究疗效判断;
(4)随机前3个月内有感染史(病毒、细菌、真菌、寄生虫感染),随机前2周内有使用全身性抗微生物治疗的感染史;
(5)有严重的胃肠道疾病(如活动性或复发性消化道溃疡),或曾经接受过可能影响药物吸收的治疗(如胃肠道手术)
(6)合并有恶性肿瘤或既往有恶性肿瘤病史;
(7)精神性疾病患者;
(8)对研究药物或研究药物中的任何成份过敏者;
(9)研究者认为不宜进行此项临床试验者;
(10)近4周内使用涉及RA治疗的中成药;
(11)近4周内使用激素口服或关节腔注射。
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Exclusion criteria:
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(1) Within 4 weeks prior to randomization, the following conditions appeared in laboratory tests and 12-lead ECG:
1) White blood cell count< 3.0×109/L;
2) Neutrophil count<1.5×109/L;
3) Hemoglobin <90.0g/L;
4) Platelet count< 100×109/L;
5) alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 times the upper limit of normal;
6) the upper limit of normal creatinine or the estimated glomerular filtration rate (eGFR) calculated by the Diet Modification for Simplified Kidney Disease (MDRD) formula <60 mL/min/1.73 m²;
7) 12-lead ECG showing clinically significant abnormalities that may affect the safety of subjects, including but not limited to acute myocardial ischemia, myocardial infarction, severe arrhythmia, or significant QTc prolongation (QTc>500ms);
(2) overlapping other autoimmune diseases such as primary/secondary Sjögren's syndrome, psoriatic arthritis, inflammatory bowel disease, ankylosing spondylitis, systemic lupus erythematosus, scleroderma or polymyositis, multiple sclerosis, fibromyalgia syndrome, etc.;
(3) Serious diseases of important organs such as cardiovascular, brain, liver, lung, kidney, and hematopoietic system, and their therapeutic drugs affect the judgment of the efficacy of this study;
(4) History of infection (viral, bacterial, fungal, parasitic infection) within 3 months before randomization, and history of infection using systemic antimicrobial therapy within 2 weeks before randomization;
(5) Have severe gastrointestinal diseases (such as active or recurrent peptic ulcers), or have received treatment that may affect drug absorption (such as gastrointestinal surgery)
(6) Combined with malignant tumors or previous history of malignant tumors;
(7) Patients with mental illness;
(8) Those who are allergic to the drug or any ingredient in the drug;
(9) Those who are considered by the investigator to be inappropriate for this clinical trial;
(10) Use of proprietary Chinese medicines involving RA treatment in the past 4 weeks;
(11) Use of glucocorticoids orally or intra-articular injection in the past 4 weeks.
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研究实施时间:
Study execute time:
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从From
2021-07-02
至To
2024-06-30
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征募观察对象时间:
Recruiting time:
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从From
2021-07-02
至To
2024-06-30
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