Clinical study for the prevention and treatment of rheumatoid arthritis by Modified Hua-Yu Qiang-Shen Tong-Bi Decoctio
- Conditions
- Rheumatoid Arthritis
- Registration Number
- ITMCTR2000004037
- Lead Sponsor
- Guangdong Provincial Hospital of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1. Subjects of the study shall meet the following diagnostic criteria:
(1) the 2010 ACR/EULAR diagnostic criteria for RA;
(2) The diagnostic criteria of TCM syndromes referS to the Guideline for Diagnosis and Treatment of Rheumatoid Arthritis combined with Syndrome and Syndrome Classification issued by The Chinese Society of Traditional Chinese Medicine in 2019. TCM syndrome differentiation is characterized by cold damp Bi syndrome and wind damp Bi syndrome;
2. According to DAS28-CRP score, patients with low activity level of the disease (DAS28-CRP 2.6 to 3.2);
3. Aged 18 to 70 years;
4. The X-ray grade of both hands is level II or below;
5. if subjects take oral glucocorticoids, the dose must be stabilized to a dose <=10mg/ d of prednisone for at least 4 weeks prior to enrollment;
6. If subjects use NSAIDs or other analgesics to treat RA, they must have received a stable dose for at least 1 week before enrollment;
7. Written informed consent to participate in the study signed by the subject or his/her family member (guardian).
(1) Those who had previously taken tripterygium wilfordii preparation, total glucoside capsules of Paeoniae alba, immunosuppression (such as salazosulfopyridine, D-penicillamine, azathioprine, chloroquine, hydroxychloroquine, cyclosporine, mycophenolate mofel, tacrolimus, elamodide, cyclophosphamide) and biological agents for less than 4 weeks after drug withdrawal; Those who had received flunomide within 12 weeks before enrollment; Had received interferon therapy within 4 weeks prior to enrollment or was expected to require interferon therapy during the study period; Those who have been vaccinated with live vaccine within 2 weeks before enrollment or need to be immunized with live vaccine during the trial period; Intraarticular injection, intramuscular injection, or intravenous glucocorticoid including adrenotrophic hormone were administered 12 weeks before enrollment;
(2) pregnancy, breastfeeding and recent family planning;
(3) Patients with serious diseases of vital organs such as cardiovascular, brain, liver, lung, kidney and hematopoietic system, acute or chronic infectious diseases, malignant tumors and mental diseases; Other autoimmune diseases such as systemic lupus erythematosus overlap; Active fibromyalgia may pose difficulties in accurately evaluating the activity of RA in this study. Preexisting pulmonary interstitial changes: 12-lead electrocardiogram (ECG) abnormalities at screening that the investigator or sponsor considers to be clinically significant and may pose an unacceptable risk to the patient's participation in the study;
(4) Allergic to methotrexate tablets;
(5) the laboratory screening test value has any of the following specific abnormalities: AST or ALT>1.2 times ULN; Hemoglobin < 90.0g /L; Total white blood cell count <3.5x10^9/L; Thrombocytopenia (platelet count <100x10^9/L); Creatinine >1.6 ULN;
(6) Those who are participating in other trials or have participated in other drug clinical trials within 2 months.
Study & Design
- Study Type
- Observational study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method visual analogue scale;ESR;Health Assessment Questionnaire;CRP;ACR20;
- Secondary Outcome Measures
Name Time Method X-ray for both hands;Morning stiffness time;DAS28-CRP;SJC28;PhGADA;Rest pain score;RF;CRP;TJC28;ACR50/70;ESR;MRI evaluation of the affected joint;PaGADA;