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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2023000011
Enrollment
Unknown
Registered
2023-05-24
Start date
2023-09-01
Completion date
Unknown
Last updated
2023-12-18

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

Conditions

acute gouty arthritis

Interventions

Control group:Loxoprofen Sodium Tablets 60mg + Tongfeng Fang granule simulant
Test group:Tongfeng Fang granule + Loxoprofen sodium analogue tablet 60mg

Sponsors

Xiyuan Hospital of China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Visual analog scale test;

Secondary

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

Countries

China

Contacts

Public ContactMa Fang

Xiyuan Hospital of China Academy of Chinese Medical Sciences

anjanette49@126.com13641090968

Outcome results

None listed

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