ITMCTR2024000092
Recruiting
Early Phase 1
Clinical evaluation of the efficacy and safety of Huayu Tongbi Fomular on rheumatoid arthritis
Guangdong Provincial Hospital of Chinese Medicine0 sitesTBD
ConditionsRheumatoid Arthritis
Overview
- Phase
- Early Phase 1
- Intervention
- Not specified
- Conditions
- Rheumatoid Arthritis
- Sponsor
- Guangdong Provincial Hospital of Chinese Medicine
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(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.
Exclusion Criteria
- •(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;
Outcomes
Primary Outcomes
Not specified
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