gout
Conditions
Interventions
Combined Chinese and Western medicine group:allopurinol and uric acid clear granules
Western Medicine Group:allopurinol
Chinese medicine group:Uric acid clearing granules
Sponsors
The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria for primary gout (2015 American College of Rheumatology/European League Against Rheumatism classification criteria for gout); 2. Previous history of gout attacks; 3. Conform to the staging standard of intermittent stage of gout (Guidelines for the Treatment of Primary Gout issued by Rheumatology Branch of Chinese Medical Association in 2011); 4. Those who meet the TCM syndrome differentiation criteria for spleen deficiency and dampness syndrome in the Primary Gout Diagnosis and Treatment Program issued by the National Central Administration in 2011; 5. Age 18-65; 6. Blood uric acid >= 480 µmol/L; 7.Blood uric acid =420umol/L in combination with any of the following conditions: gout attack =2 times/year age of onset <40 years old kidney stones chronic kidney disease hypertension diabetes mellitus dyslipidemia. 8. Those who voluntarily participate in this trial and agree to enter the clinical research and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients who are in the acute attack stage of gouty arthritis or combined with gout stones at the time of screening. (2) Allergic patients with known allergy to allopurinol or Chinese medicine. (3) Severe acute and chronic organic or psychiatric diseases. (4)Pregnant and lactating women. (5) Patients with chronic kidney disease stage III-V ( eGFR) < 60 ml/min/1.73 m2). (6) Abnormal liver function: blood ALT AST exceeds the normal value more than 1.5 times. (7) Use of other uric acid-lowering drugs (allopurinol febuxostat probenecid benzbromarone recombinant uricase) within 2 weeks before randomization (8) Subjects who in the opinion of the investigator have poor compliance which affects the evaluation of the safety and efficacy of the test drug and who are unable to complete the clinical study. Translated with www.DeepL.com/Translator (free version)
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Inflammation indicators (C-reactive protein, blood sedimentation);Kidney function (Serum creatinine, urea nitrogen, glomerular filtration rate);The frequency of acute gout attack;Changes in the intestinal flora;TCM syndrome score; | — |
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in blood uric acid at each time point;Blood uric acid compliance rate;Percentage change from baseline in blood uric acid at each time point; | — |
Countries
China
Contacts
Public ContactZhaofu Li
Yunnan University of Traditional Chinese Medicine
Outcome results
None listed