hyperuricemia
Conditions
Interventions
Observation group:AI-augmented Traditional Chinese Medicine prescription (250 mL/dose BID p.o.) developed by rheumatologists
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1)Meet any one of the following conditions: 1) Serum uric acid (SUA) >480 µmol/L with at least one comorbidity (hypertension diabetes or hyperlipidemia); 2) Asymptomatic hyperuricemia with SUA >540 µmol/L; 3) Diagnosed with gout (based on 2015 ACR/EULAR classification criteria). (2) Aged 18-65 years (male or female). (3) No urate-lowering drugs used in the past 2 weeks. (4) Signed informed consent form.
Exclusion criteria
Exclusion criteria: (1) Severe cardiovascular endocrine digestive or hematologic diseases. (2) ALT >1.5× upper limit of normal (ULN) during screening. (3) eGFR <30 mL/min/1.73 m² during screening. (4) Pregnant/lactating women or individuals planning pregnancy (male/female). (5) Secondary gout caused by other diseases (e.g. tumor lysis syndrome). (6) Other conditions that may interfere with trial results (per investigators judgment).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in SUA levels from baselineFrequency of gout flares (acute attacks); | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Gout Outcome Measures (GOM) scale score;Metabolic and renal parameters: Blood pressure Blood glucose Lipid profile Serum creatinine Estimated glomerular filtration rate (eGFR);Variation in TCM syndrome score (per standardized TCM diagnostic criteria);Frequency of NSAID usage during treatment period;Proportion of patients achieving serum uric acid (SUA) <360 µmol/L at 12 weeks;Changes in inflammatory markers: C-reactive protein (CRP) Erythrocyte sedimentation rate (ESR) Pan-inflammatory indicators;The frequence of gout flares; | — |
Countries
China
Contacts
Public ContactZhengdong Shen
Zhuhai Branch of Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed