Clinical study of Uric acid clear granules in the treatment of gout

Clinical study of Uric acid clear granules in the treatment of gout intermittent phase (spleen deficiency and moisture obstruction) and its effect on intestinal flora

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300068545

Enrollment

Unknown

Registered

2023-02-22

Start date

2023-03-06

Completion date

Unknown

Last updated

2023-05-22

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

Conditions

gout

Interventions

Experimental group:uric acid clear granules

Control group:benzbromarone,sodium bicarbonate

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Meets diagnostic criteria for primary gout (2015 American College of Rheumatology/European League Against Rheumatism Gout Classification Criteria). (2) Previous history of gout attacks. (3) Those who meet the Chinese medical criteria of the 2011 NCCA "Primary Gout Treatment Protocol" for the identification of spleen deficiency and dampness obstruction. (4) Meet the Chinese medical criteria for identifying spleen deficiency and dampness obstruction in the 2011 NCCA Primary Gout Treatment Protocol. (5) Age 18 to 65 years. (6) Blood uric acid= 480µmol/L. (7) Those who voluntarily participate in this trial and agree to enter the clinical study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients who are in the acute phase of gouty arthritis or have a combination of gout stones or kidney stones at the time of screening. (2) Allergic persons, known to be allergic to benzbromarone or herbal medicines. (3) Severe acute and chronic organic or psychiatric diseases. (4) Women during pregnancy and lactation. (5) Patients with chronic renal disease stage III-V ( e GFR ) < 60 ml/min/1.73 m2). (6) Abnormal liver function: blood ALT and AST more than 1 times the normal value. (7) Those with poor compliance and inability to complete clinical observation.

Design outcomes

Primary

Measure	Time frame
the proportion of patients achieving the SUA target (SUA< 360 µmol/L);serum uric acid levels at each point of measurement;	—

Secondary

Measure	Time frame
The frequency of acute gout attack;TCM syndrome score;Kidney function (Serum creatinine, urea nitrogen, glomerular filtration rate);Inflammatory indicators (C-reactive protein, erythrocyte sedimentation rate, interleukin-6);Changes in the intestinal flora;	—

Countries

China

Contacts

Public ContactZhaofu Li

The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine

lzf0817@126.com+86 13187442840

Outcome results

None listed

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