Clinical Observation on the Therapeutic Effect of Jianpi Shenshi Granule on Gout Stone(Spleen Deficiency and Dampness Resistance Type)

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300071056

Enrollment

Unknown

Registered

2023-05-04

Start date

2023-05-01

Completion date

Unknown

Last updated

2023-06-04

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

Conditions

Gout Stone

Interventions

Treatment group:Febuxostat + Jianpi Shenshi Granule

Control group:Febuxostat

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Those who meet the 2015 ACR/ EULAR classification standard on gout and are in remission stage of gout attack; (2) It meets the diagnostic criteria of tophi, and the number of tophi is = 1; (3) TCM syndrome type is spleen deficiency and dampness resistance; (4) The acute attack occurred 2 weeks ago, and Chinese and western medicines for lowering UA were not taken within 2 weeks; (5) Sex is not limited, and the age is between 18 and 65 years old; (6) No serious primary diseases associated with other systems; (7) Patients treated in our hospital with complete clinical data; (8) Informed consent, voluntary subjects, and the process of obtaining informed consent is in line with GCP regulations.

Exclusion criteria

Exclusion criteria: (1) Bone and joint nodules and bone and joint destroyers caused by other reasons (rheumatoid arthritis, rheumatoid arthritis, osteoarthritis, etc.); (2) Patients receiving azathioprine and mercaptopurine treatment; (3) Those who have adverse drug reactions; (4) Pregnant or lactating women; (5) Gout stone ulceration or secondary infection; (6) Cardio-cerebrovascular disease; (7) Patients requiring surgical treatment; (8) Allergic constitution, known to be allergic to the components of this drug; (9) Patients participating in clinical trials of other drugs; (10) Serious mental disorder; (11) Patients with secondary hyperuricemia, hypertension, diabetes, tumor, thyroid disease, liver and kidney dysfunction.

Design outcomes

Primary

Measure	Time frame
Gout stone;	—

Secondary

Measure	Time frame
Serum uric acid;Number of episodes of acute gouty arthritis;C-reactive protein;Erythrocyte sedimentation rate;TCM syndrome score;Renal function;	—

Countries

China

Contacts

Public ContactLi Zhaofu

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