Gouty arthritis
Conditions
Interventions
Treatment group:Zexie Huazhuo decoction
Sponsors
Institute Of Basic Research In Clinical Medicine, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in the trial and sign the informed consent; 2. Age above 18 years old, regardless of gender; 3. In accordance with the western medical diagnostic criteria for gouty arthritis (2015 American College of Rheumatology (ACR) and European League against Rheumatism (EULAR) classification criteria for gout); 4. Meet the syndrome differentiation criteria of TCM damp-heat blocking collaterals in acute gouty arthritis (refer to the International Clinical Practice Guidelines for TCM Gout (2024-03-14) formulated by the World Federation of Chinese Medicine Associations in 2024); 5. A history of more than one spontaneous gouty arthritis episode within 12 months; 6. Number of involved joints =4; 7. A history of gouty arthritis episodes characterized by severe pain of moderate or greater intensity (VAS score =40mm) within 48 hours before assessment; 8.If urate-lowering therapy was being administered, it had to be taken at a stable dose for 2 weeks before enrollment and had to be maintained during participation in the study.
Exclusion criteria
Exclusion criteria: 1. Use of specific pain medication or biological agents (including glucocorticoids, anesthetics, acetaminophen, NSAIDs, colchicine, IL receptor blockers, and tumor necrosis factor inhibitors) within 48h before enrollment; 2. A history of more than 12 acute gouty arthritis episodes within 6 months before enrollment; 3. Patients with confirmed or suspected rheumatoid arthritis, infectious/septic arthritis or other acute inflammatory arthritis; 4. History of malignant tumor in the past 5 years; 5. Presence/suspicion of active or recurrent bacterial, fungal or viral infection (including tuberculosis, HIV infection, hepatitis B or C infection); 6. Severe renal impairment with serum creatinine > 1.5 times the upper limit of normal, or chronic kidney disease (CKD4 stage and CK5 stage); 7. Neutropenia; 8. Severe abnormal liver function, ALT or AST > 1.5 times the upper limit of normal; 9. Patients with uncontrolled diabetes mellitus and glycated hemoglobin A1c > 1.0 times the upper limit of normal; 10. A history of myocardial infarction, unstable angina, cerebrovascular event, coronary artery bypass grafting, or New York Heart Association (NYHA) class III or IV heart failure within the past 3 months; 11. Patients with asthma, chronic obstructive pulmonary disease, polyneuritis, myasthenia gravis and muscular atrophy; 12. Patients with severe dyspepsia, gastrointestinal obstruction, gastric and duodenal ulcers, and other gastrointestinal diseases that may affect drug absorption; 13. Patients with a history of epilepsy, alcoholism or psychotropic drug abuse; 14. Those who underwent major surgery within 2 weeks or had unhealed surgical wounds; 15.Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in VAS(Visual Analogue Scale) from baseline to day 3 of treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in VAS(Visual Analogue Scale) from baseline to 6h-15 days of treatment.;The median time for efficacy to take effect;Response median time;The median time for pain relief;The median time for the first administration of emergency medication;The physician's assessment of the overall response to the treatment;The physician's assessment of the "swelling degree" sign of the most affected joint;The physician's assessment of the "erythema" signs of the most affected joint;The physician's assessment of "tender points" in the most affected joints;Evaluation of the patient's overall response to the treatment;Compared with the baseline, the changes in the traditional Chinese medicine symptom scores on the 1st, 3rd, 5th, 10th, and 15th days after medication administration;Compared with the baseline, the changes of WBC (White Blood Cell), ESR (Erythrocyte Sedimentation Rate), CRP (C-Reactive Protein), CXCR2 (C-X-C Motif Chemokine Receptor 2), CXCL5 (C-X-C Motif Chemokine Ligand 5), Trpa1 (Transient Receptor Potential Ankyrin 1), TNF-a (Tumor Necrosis Factor-alpha), IL-1ß (Interleukin-1 beta), IL-6 (Interleukin-6), TLR4 (Toll-like Receptor 4), MyD88 (Myeloid Differentiation Primary Response 88), NF-?B (Nuclear Factor Kappa-Light-Chain-Enhancer of Activated B Cells), I?Ba (Inhibitor of Kappa B Alpha), NLRP3 (NLR Family Pyrin Domain Containing 3), PTGS2 (Prostaglandin-Endoperoxide Synthase 2), IL-17 (Interleukin-17) and HIF1A (Hypoxia-Inducible Factor 1-Alpha) on the 5th day after medication administration.;Compared with the baseline, the changes in the EQ-5D-5L (EuroQol 5-Dimension 5-Level)score on the 10th and 15th days after medication administration; | — |
Countries
China
Contacts
Public ContactWang Zhong
Institute Of Basic Research In Clinical Medicine, China Academy of Chinese Medical Sciences
Outcome results
None listed