rheumatoid arthritis
Conditions
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. The subjects of the study should meet the following diagnostic criteria: (1) Western medical diagnostic criteria: the RA classification criteria of the 2010 ACR/EULAR were used for comprehensive judgment; (2) The diagnostic criteria of TCM syndrome refer to the diagnostic criteria of the 2011 Consensus on the Diagnosis and Treatment of Blood Stasis Pattern with Integrated Traditional Chinese and Western Medicine, and the TCM syndrome differentiation is blood stasis pattern; 2. Patients with moderately low activity according to the DAS28-CRP score (2.6< DAS28-CRP <5.1); 3. Age 18~70 years old; 4. Two-hand X-ray grade III and below; 5. If the subject is treated with traditional remission anti-rheumatic drugs (DMARDs), or JAK enzyme inhibitors (including tofacib, baritinib), fusion protein organisms (including Isep, strong, Aberno, Enli, etc.), and organisms (including adalimumab, infliximab, mab, etc.) must be treated at a stable dose for at least 2 weeks before enrollment; 6. If subjects take oral glucocorticoids, their dose must be stable to a dose equivalent to <=10mg/day of prednisone for at least 4 weeks prior to enrollment; If discontinued, oral glucocorticoids should be discontinued at least 2 weeks prior to enrollment; 7. If subjects are treated with non-steroidal anti-inflammatory drugs (NSAIDs) or other analgesics for RA, they must have been on a stable dose for at least 2 weeks prior to enrollment; If not used, NSAIDs must be discontinued for more than 2 weeks prior to enrollment; 8. Written informed consent signed by the subject or his/her family (guardian) to participate in this trial.
Exclusion criteria
Exclusion criteria: 1. Those who have previously taken Tripterygium wilfordii and stopped taking the drug 1.2 times ULN; (2) Hemoglobin 1.6 upper limit of normal; 11. 12-lead electrocardiogram (ECG) abnormality at screening, which in the opinion of the investigator or sponsor is clinically significant and may pose an unacceptable risk to the patient's participation in this study; 12. Those who are participating in other trials or have participated in other drug clinical trials within 2 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RF;CCP;ESR;CRP;ACR20; | — |
Secondary
| Measure | Time frame |
|---|---|
| X-rays of both hands;Rest pain score;Morning stiffness time;SJC28;TJC28;Health Assessment Questionnaire;DAS28;ACR50/70; | — |
Countries
China
Contacts
Public ContactHuang Runyue
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed