Efficacy evaluation of Tongfeng Fang and its influence on reconstruction of gut microbiome and immune function in acute gouty arthritis

Not Applicable

Recruiting

• Conditions: acute gouty arthritis

• Registration Number: ITMCTR2023000011
• Lead Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 18 December 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

?Those who meet the diagnostic criteria of primary acute gouty arthritis and the syndrome differentiation criteria of TCM damp-heat syndrome.
? Male and female patients aged 18-70 years.
?Acute onset, the course of the attack within 48 hours.
?No relevant therapeutic drugs have been taken since the onset of the disease.
?Informed consent, voluntary subjects.

Exclusion Criteria

?Secondary gout, such as renal failure, tumor chemotherapy and/or radiotherapy;
?Patients who were allergic to the drug in this study;
?Have serious heart, liver, lung, hematopoietic system or affect their survival of serious diseases, such as tumor, AIDS; ALT or AST > 2N (N is the upper limit of normal); SCr=132mmol/L (1.5 mg/dl); Arrhythmia of clinical significance; white blood cell<3.0 times 10^9/L;
?Joint lesions caused by rheumatoid arthritis, pyogenic arthritis, traumatic arthritis, psoriatic arthritis, pseudogout, lupus erythematosus and other diseases;
?Hyperuricemia and gout caused by diuretics, compound antihypertensive drugs containing diuretics, ethambutol, pyrazinamide, aspirin and other drugs;
?Hyperuricemia and gout caused by diuretics, compound antihypertensive drugs containing diuretics, ethambutol, pyrazinamide, aspirin and other drugs;
?Pregnant and lactating women;
?Suspected or indeed a history of alcohol or drug abuse, or according to the judgment of the researchers, with the possibility of reducing or complicating the inclusion of other lesions, such as frequent changes in the working environment and other easy to cause the loss of follow-up.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual analog scale test;

Secondary Outcome Measures

Name	Time	Method
blood uric acid;TCM syndrome score;C-reactive protein;Time to onset of pain relief;