Rheumatoid Arthritis
Conditions
Interventions
Placebo group:Quyu Qingfei Formula Simulation Agent (using a simulation agent containing 5% of the original Quyu Qingfei Formula ingredients), one dose per day, taken in two divided doses, taken warm
Treatment group:Quyu Qingfei Formula, one dose per day, taken in two divided doses, taken warm after meals, with the original treatment medications maintained at a stable therapeutic dose, treatment c
Sponsors
Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18-75 years old, with independent capacity, regardless of gender; (2) Comply with the 1987 American College of Rheumatology(ACR) RA classification standard and/or the 2010 ACR/The European Alliance of Associations for Rheumatology (EULAR) RA classification standard; (3) RA remission or low disease activity, Disease Activity Score in 28 Joints - Erythrocyte Sedimentation Rate(DAS28-ESR)=3.2; (4) The lung High Resolution CT(HRCT) within 12 months showed the presence of interstitial pneumonia and no improvement in lung function or clinically significant improvement in interstitial lung disease (ILD) for 3 months = on stable treatment: i.e., no improvement in absolute forced vital capacity (FVC) % of predicted value within 12 months to Visit 1 (inclusive>). 5% or based on clinician assessment (including symptoms, imaging tests/HRCT, or other assessments deemed relevant and documented by the investigator) considered ILD to require further intervention; (5) Pulmonary function test within 3 months (including the screening period) showed that FVC = 45% of the normal predicted value, Diffusing Capacity of the Lung for Carbon Monoxide(DLCO) = 30% of the normal predicted value corrected by hemoglobin (Hb); (6) RA-ILD in line with liver and kidney yin deficiency syndrome: Description: Refer to the relevant content of paralysis and asthma in the "Guiding Principles for Clinical Research of New Drugs in Traditional Chinese Medicine (Trial)" and "Diagnostic Efficacy Standards for Internal Diseases of Traditional Chinese Medicine", the main symptoms: chronic joint swelling and deformity, unfavorable flexion and extension, morning stiffness, wheezing and holding breath, chest tightness and shortness of breath, cough and sputum. Secondary symptoms: sore waist and knees, dizziness, irritability, dry throat, hot flashes, night sweats. Tongue pulse: The tongue is red, the moss is small, and the pulse is deep and thin. It has 2 main symptoms and 2 secondary symptoms: or 1 main symptom and 3 secondary symptoms, which can be diagnosed by combining the tongue pulse; (7) Nonsteroidal anti-inflammatory drugs (NSAIDs) or other analgesic treatment, which must be treated at a stable dose for at least 2 weeks before enrollment; (8) If oral corticosteroids are administered, the dose must be stable to a dose equivalent to = 10 mg prednisone/day for at least 4 weeks prior to the first dose of study drug prior to enrollment. If glucocorticoids are not used, oral corticosteroids should not be taken at least 2 weeks before inclusion; (9) Meet the following tuberculosis screening criteria: 1) No history of active tuberculosis: 2) No recent close contact history with active tuberculosis patients: 3) No symptoms or signs of active tuberculosis found in medical history and physical examination: 4) Chest CT taken within 3 months before enrollment, confirming no evidence of active tuberculosis; 5) Negative interferon ? tuberculosis release test within 6 weeks before enrollment; (10) Meet the following laboratory test standards: blood routine: neutrophil count (NEUT) = 1.0*10^9/L; Lymphocyte count (LYMPH) =0.5*10^9/L; Hemoglobin (HGB) >80g/L; Platelet count (PLT) > 80*10^9/L. Liver: Aspartate transferase (AST), alanine transferase (ALT), total bilirubin (TBIL) not higher than 1.5 times the upper limit of normal. Renal: estimated Glomerular Filtration Rate(eGFR)>60ml/min; (11) Patients gave informed consent and agreed to participate in this study.
Exclusion criteria
Exclusion criteria: (1) Secondary to other connective tissue diseases; (2) Combined with other lung diseases, such as lung infections, asthma, tuberculosis, chronic obstructive pulmonary disease, bronchiectasis, and lung tumors; (3) Interstitial lung disease caused by pneumoconiosis, inhalation of organic substances, or drugs; (4) Severe organ damage (heart, brain, liver, kidney, lung, etc.), known malignant tumors, or a history of malignant tumors within the past 5 years, venous thromboembolism, significant or poorly controlled dyslipidemia, or severe infection; patients with psychiatric disorders; (5) Active infection within 3 months prior to the first study drug administration, including shingles, mycobacterial infection, opportunistic infections, etc.; (6) Acute exacerbation of ILD within 3 months prior to the first study drug administration or during screening; (7) Use of or planned use of vaccination within 3 months prior to the first study drug administration, during the study, or within 6 months after the last study drug administration; (8) Positive for hepatitis B DNA, hepatitis C RNA, or HIV antibodies; (9) Allergic to study drugs or contraindicated for use; pregnant or breastfeeding women; male patients with fertility requirements; (10) Any situation in which the investigator considers the subject's participation in the study to carry unacceptable risks. If your doctor determines that you meet the requirements to participate in this study and you voluntarily choose to participate, you will have a total of 6 visits, which will be at the screening prior to treatment, and at weeks 0, 4, 12, 24, 36, and 48. During each visit, the doctor will need to evaluate your efficacy and safety indicators as required by the study, as well as your personal quality of life indicators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Forced Vital Capacity (FVC) decline rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean absolute change in forced vital capacity (FVC) at weeks 0, 24, and 48, and percentage of predicted value for carbon monoxide diffusing capacity (DLCO);Time of first ILD exacerbation, number of hospitalizations due to ILD, time of death;Absolute change from baseline in quantitative interstitial lung disease (QILD) score [%];Absolute change from baseline in Quantitative Lung Fibrosis (QLF) score [%];Absolute change from baseline in quantitative ground-glass opacity (QGGO) score [%];Absolute change from baseline in the dyspnea domain score of the Lung Fibrosis Patient (L-PF) quality of life; | — |
Countries
People's Republic of China
Contacts
Public ContactHe Dongyi
Department of Rheumatology, Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
Outcome results
None listed