gout
Conditions
Interventions
treatment group:Bixie Zelan decoction modified formula
control group:Placebo
Sponsors
Beijing Huairou Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Meet the diagnostic criteria for intermittent gout (the gout classification criteria jointly developed by the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) in 2015); 2) Chinese medicine diagnosis meets the diagnostic criteria of spleen and kidney deficiency and dampness-heat accumulation syndrome; 3) Age 18-65 years old, gender is not limited; 4) Blood uric acid>480µmol/L or blood uric acid>420µmol/L and combined with any of the following conditions: gout attack =2 times/year, gout stone; 5) Those who can accept the control of blood uric acid through diet, lifestyle modification and regular oral febuxostat; (6) Patients who have a full understanding of this study, voluntarily participate in this clinical study, are willing to accept oral herbal treatment, can provide detailed contact information, are willing to cooperate with the visit, and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1) secondary hyperuricemia and gout (e.g. decreased uric acid excretion due to renal disease, increased uric acid production due to myeloproliferative disease and tumor radiotherapy, taking drugs to inhibit uric acid excretion, etc.); 2) refractory gout (with at least one of the following three: 1) using alone or in combination with conventional uric acid-lowering drugs in sufficient quantities and courses, but the blood uric acid is still =360 µmol/L; 2) receiving standardized treatment, gout is still attacked =2 times/year; 3) the presence of multiple and/or progressive gout stones); (iii) People with acute gout attack within 2 weeks before enrollment; 4) Those who have used allopurinol, benzbromarone or febuxostat within 4 weeks before enrollment; 5) Those who have used local joint cavity hormone injection therapy within 4 weeks before enrollment; those who have taken oral colchicine, glucocorticoids, NSAIDs or COX-2 inhibitors within 1 week before enrollment; (vi) Those with active liver disease or abnormal liver function, with AST, ALT or GGT higher than 1.2 times the upper limit of normal value; (vii) Those with abnormal renal function, with serum creatinine concentration (SCr) higher than 1.2 times the upper limit of normal value; 8) patients with a history of peptic ulcer and gastrointestinal bleeding; 9) are taking drugs that interact with febuxostat, celecoxib; 10)Persons who are allergic or intolerant to any component of febuxostat, celecoxib and other test drugs; 11) having various other conditions that, in the opinion of the investigator, make participation in this clinical study inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of acute gout flares in subjects within 12weeks of the treatment period; | — |
Secondary
| Measure | Time frame |
|---|---|
| The oral dose of celecoxib will be used to control the onset of acute gout within 12 weeks;Total number of acute gouty flares;Traditional Chinese Medicine Syndrome Score Scale;The semi-quantitative ultrasound scoring system for gout lesions of involved joints;The compliance rate of patients whose UA levels are =360mmol/L at each visit time point; | — |
Countries
china
Contacts
Public ContactWenchao Bian
Beijing Huairou Hospital of Traditional Chinese Medicine
Outcome results
None listed