ITMCTR2024000092招募中1 期
Clinical evaluation of the efficacy and safety of Huayu Tongbi Fomular on rheumatoid arthritis
Guangdong Provincial Hospital of Chinese Medicine0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 70（—）
- 性别
- All
入选标准
- •(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.
排除标准
- •(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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