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Effect of Jianpi Qushi Recipe on hyperuricemia patients and the serum levels of inflammatory cytokines

A randomized, comparison pharmacokinetic study of Jianpi Qushi Recipe and Febuxostat in Chinese hyperuricemia patients

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200005783
Enrollment
Unknown
Registered
2022-03-29
Start date
2022-04-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

hyperuricemia patients

Interventions

The control group:Oral febuxostat treatment+ Lifestyle adjustment (diet, exercise)
The experimental group:Oral invigorating spleen and removing dampness prescription+ Lifestyle adjustment (diet, exercise)

Sponsors

Department of Immunity,the Tianjin FirstHospital,Tianjin,
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The standard age was 18-65 years old, with no gender limitation.The inclusion criteria met the diagnostic criteria set by Multidisciplinary Expert Consensus on diagnosis and Treatment of Hyperuricemia Related Diseases in China (2017) : for both men and women, fasting uric acid level exceeded 420µmol/L, which was called hyperuricemia.

Exclusion criteria

Exclusion criteria: Secondary gout caused by kidney disease, blood disease, taking drugs, tumor radiation and chemotherapy, etc. In the acute onset of gouty arthritis; Caused by rheumatoid arthritis, psoriatic arthritis, bone tumors and other joint lesions; With serious pulmonary, cardiovascular, hematopoietic, central nervous system or other systemic diseases; Complicated with malignant tumor; Glutamic-pyruvic transaminase or glutamic-oxalacetic transaminase was 1.5 times higher than the upper limit of normal range; Serum creatinine was higher than the upper limit of normal range; Had undergone sex hormone replacement therapy and oral contraception in the past 3 months; Taking more than 10 mg/d of prednisone or other equivalent glucocorticoids; Or failing to take medication as prescribed. Pregnant or breast-feeding women or those who plan to become pregnant; Allergic to test drugs, weak physique or allergic constitution: those who meet any one of the above criteria can be excluded from the study.

Design outcomes

Primary

MeasureTime frame
The level of TNF-?;IL-1ß;Blood uric acid;

Secondary

MeasureTime frame
Number of new episodes of hematuria soreness and wind during each visit;renal function;C-reactive protein;Blood sedimentation;Liver function;

Countries

china

Contacts

Public ContactChunye Wu
wuchunye@163.com18822002051

Outcome results

None listed

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