acute gouty arthritis
Conditions
Interventions
Sponsors
Affiliated Hospital of Qingdao University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Meets the 2015 ACR/EULAR classification and diagnostic criteria for gout; (2) In line with the diagnostic criteria of "rheumatism and heat stagnation" for gout in the "Standards for Diagnosis and Efficacy of Diseases and Syndromes of Traditional Chinese Medicine" issued by the State Administration of Traditional Chinese Medicine in 2017; (3) The course of the attack was within 48 hours when randomly enrolled;Patients who have not used any therapeutic drugs (including colchicine, non-steroidal anti-inflammatory drugs and hormones) during this episode; (4) Aged between 18 and 75 years, gender is not limited. (5) Patients who signed the informed consent to take the medication as required by the study protocol and were evaluated.
Exclusion criteria
Exclusion criteria: (1) Secondary gout, joint lesions caused by other diseases (such as rheumatoid arthritis, pyogenic arthritis, traumatic arthritis, silver-dural arthritis, pseudogout, lupus erythematosus, etc.);Chemotherapy, radiotherapy, chronic lead poisoning, acute obstructive kidney disease and other joint lesions; (2) Patients with advanced deformity, disability, loss of working ability, and cardiovascular and cerebrovascular diseases induced by pain; (3) Have severe cardiovascular disease, liver disease, renal disease, hematologic disease, lung disease, or other serious disease affecting their survival, such as tumor or AIDS; (4) ALT > 2 times the upper limit of normal; CR > upper limit of normal value; Urinary protein >+; Arrhythmias of clinical significance. (5) Are taking drugs for blood uric acid metabolism, such as dihydroclorazide, furosemide, diuric acid, pyrazinamide, low-dose aspirin, etc., as well as drugs containing the above-mentioned ingredients, such as compound antihypertensive tablets;Or had taken glucocorticoids within 1 month before enrollment; Or use of nonsteroidal anti-inflammatory drugs or other pain medications within 48 hours prior to baseline evaluation; (6) Women who are pregnant, lactating or have a recent birth plan; (7) Patients with active gastrointestinal ulcer or taking anti-ulcer drugs; (8) People with mental or legal disabilities (9) Suspected or confirmed history of alcohol or drug abuse, or other diseases that, according to the investigator's judgment, reduce the possibility of inclusion or complicate inclusion, such as frequent changes in the work environment, which may easily cause loss of follow-up; (10) People who are known to be allergic to the components of this drug; (11) Those who have participated in or are participating in clinical trials within the last 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in VAS scores before and after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time for joint pain to disappear;Changes in joint swelling scores after treatment;Changes in joint tenderness scores after treatment;Evaluation criteria for efficacy of TCM syndromes;Evaluation criteria for patients' overall treatment effect after the end of treatment;Changes of laboratory indicators (serum uric acid, C-reactive protein, erythrocyte sedimentation rate) before and after treatment;The recurrence rate of acute gouty arthritis until the end of follow-up;The utilization rate of analgesic drugs; | — |
Countries
China
Contacts
Public ContactYangang Wang
Affiliated Hospital of Qingdao University
Outcome results
None listed