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Quzhuo Tongbi Formula prevents gout flares in the process of ULT A randomized controlled clinical trial

Quzhuo Tongbi Formula prevents gout flares in the process of ULT A randomized controlled clinical trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084417
Enrollment
Unknown
Registered
2024-05-16
Start date
2024-06-01
Completion date
Unknown
Last updated
2024-05-21

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

Conditions

gout

Interventions

Treatment group:Quzhuo Tongbi Granules+Febuxostat
control group:Chinese herbal placebo+Febuxostat

Sponsors

Zhejiang Chinese Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Meets the 2015 ACR/EULAR diagnostic criteria for gout and is determined to be in a period of intermittent gout; (2) Traditional Chinese medicine syndrome differentiation is for patients with spleen deficiency and dampness obstruction syndrome; (3) Serum urate level = 7mg/dL (420) µ Mol/L); (4) Between the ages of 18 and 80 (including boundary values), regardless of gender; (5) I have not received any uric acid lowering drugs such as allopurinol, benzbromarone, or febuxostat in the past month; (6) Alleviation of joint symptoms in acute gouty arthritis (VAS score 0) for more than 1 week; (7) A history of two or more acute gout attacks in the past year; (8) Voluntarily accept treatment and sign an informed consent form.

Exclusion criteria

Exclusion criteria: (1) Severe liver and kidney dysfunction (AST/ALT more than twice normal, eGFR<60ml/min), hypertension grade I and above, diabetes with target organ damage, severe cardiovascular and cerebrovascular diseases, peptic ulcer with bleeding, perforation and psychosis in the past; (2) Patients who are intolerant or have contraindications to the drugs used in this study (such as uric acid lowering drugs, traditional Chinese medicine, and non steroidal anti-inflammatory drugs); (3) Patients with hyperuricemia caused by bone marrow proliferative disease or other diseases with obvious uric acid excess ("secondary gout"); (4) Pregnant or lactating patients.

Design outcomes

Primary

MeasureTime frame
Number of gout attacks;

Secondary

MeasureTime frame
Duration of each gout attack (days);Quality of Life;Target rate of uric acid lowering treatment;Randomly assigned to the time span of the first acute exacerbation;

Countries

China

Contacts

Public ContactLin Huang

Zhejiang Chinese Medical University

huanglin@zcmu.edu.cn+86 135 8807 8467

Outcome results

None listed

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