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Clinical study of Bixie Zelan Decoction in the treatment of acute gouty arthritis with dampness and heat accumulation

Clinical study of Bixie Zelan Decoction in the treatment of acute gouty arthritis with dampness and heat accumulation

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200006856
Enrollment
Unknown
Registered
2022-12-08
Start date
2022-12-08
Completion date
Unknown
Last updated
2023-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gout

Interventions

Test group:Take loxprofen sodium tablets orally + Take Bixie Zelan Decoction orally
Control group:Take loxprofen sodium tablets orally

Sponsors

Beijing Huairou Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 75 Years

Inclusion criteria

Inclusion criteria: (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.

Exclusion criteria

Exclusion criteria: (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.

Design outcomes

Primary

MeasureTime frame
blood uric acid;c-reactive protein;

Secondary

MeasureTime frame
erythrocyte sedimentation rate (ESR);Musculoskeletal ultrasound;

Countries

China

Contacts

Public ContactBian Wenchao

Beijing Huairou Hospital of Traditional Chinese Medicine

1056782409@qq.com18511181007

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026