Gouty arthritis
Conditions
Interventions
Experimental Group:(Acute phase) Swelling pain aerosol + Colchicine, (Intermittent phase) Pain relief capsule + Febuxostat
Control group (acute phase):Colchicine (acute phase) + Febuxostat (intermittent phase)
Sponsors
Yunnan Provincial Traditional Chinese Medicine Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Meets the 2015 ACR gout diagnostic criteria, acute attack =48 hours [5], target joint pain VAS score (0-100mm) =40mm; 2) 18 years = age =75 years, both males and females; 3) Expected to comply with follow-up, willing to accept urate-lowering therapy after acute attack resolution, and not participating in other clinical studies at the same time; 4) Voluntarily signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Known to be allergic to the investigational drug (anti-inflammatory spray/pain-relief capsule/colchicine/febuxostat) or have contraindications; 2) Currently diagnosed with active gastrointestinal diseases, or history of gastrointestinal ulcers, bleeding, or gastrointestinal surgery within the past 30 days; 3) Currently undergoing anticoagulation therapy; 4) Blood tests showing clinically significant abnormalities or eGFR 4 joints); 7) Use of urate-lowering therapy, glucocorticoids, colchicine/nonsteroidal anti-inflammatory drugs, or other analgesics, or traditional Chinese medicine formulations within 48 hours prior to enrollment; 8) Use of long-acting opioid medications within 14 days prior to screening, or use of biologics within 30 days prior to screening; 9) Confirmed diagnosis of secondary gout, or confirmed diagnosis of joint pain caused by trauma, rheumatism, rheumatoid arthritis, or infection; 10) Affected joints with wounds, infection, severe deformity, or other conditions that may impact treatment or assessment; 11) Pregnant or breastfeeding women, or women of childbearing potential who refuse to use highly effective contraceptive measures during the study period; 12) Other conditions assessed by the investigator that may affect the evaluation of efficacy or safety in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in target joint pain VAS score from baseline.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain VAS score of the target joint;The time when the pain intensity in the target joint first decreased to =50% of baseline.;Target Joint Pain Relief Time;The change in joint swelling severity from baseline;Change in joint range of motion from baseline value;Serum uric acid;Proportion of patients with serum uric acid <360 µmol/L.;Time of first acute gout attack onset during Day 8-35;The proportion of subjects who experienced at least one acute exacerbation between Day 8 and Day 35.;Rescue therapy utilization within 7 days and within 8-35 days;Subject Treatment Satisfaction Likert Scale Scores; | — |
Countries
China
Contacts
Public ContactGu Haichao
Yunnan Provincial Traditional Chinese Medicine Hospital
Outcome results
None listed