Clinical study of Bixie Zelan Decoction in the treatment of acute gouty arthritis with dampness and heat accumulatio
- Conditions
- gout
- Registration Number
- ITMCTR2200006856
- Lead Sponsor
- Beijing Huairou Hospital of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
(1) TCM syndrome differentiation meets the diagnostic criteria of dampness and heat accumulation type;
(2) The diagnosis of Western medicine meets the diagnostic criteria of acute gouty arthritis;
(3) Age range: 20-75 years old, gender unlimited;
(4) no colchicine, NSAIDs, glucocorticoids or traditional Chinese medicine preparations were used in the past 1 week;
(5) Patients who fully understand this study, voluntarily participate in this clinical study, are willing to accept oral chinese medicine treatment, actively cooperate, can complete clinical observation, and sign the informed consent letter, can complete the follow-up as scheduled.
(1) Secondary hyperuricemia and gout: reduced uric acid excretion due to kidney disease, increased uric acid production due to bone marrow hypertrophic disease and radiotherapy, and taking drugs that inhibit uric acid excretion, etc.;
(2) Refractory gout patients (with at least one of the following three: (1) Sufficient amount and full course of routine urate-lowering drugs alone or in combination, but blood uric acid is still =360umol/L; (2) Gout still occurs =2 times per year after receiving standardized treatment; (3) the presence of multiple and/or progressive tophones);
(3) Patients with severe systemic diseases such as liver function, renal function and cardiac insufficiency;
(4) previous gastrointestinal ulcer, bleeding, perforation;
(5) long-term oral low-dose aspirin anticoagulant therapy;
(6) Serious disease: such as severe joint deformity or ankylosis, the formation of tophones with local infection, ulceration or nerve compression;
(7) Patients with mental disorders, senile dementia and communication disorders who cannot cooperate;
(8) Pregnant or lactating women.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method blood uric acid;c-reactive protein;
- Secondary Outcome Measures
Name Time Method erythrocyte sedimentation rate (ESR);Musculoskeletal ultrasound;