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Clinical and Mechanism Study on Qifu Huazhuo Formula in Treating intercritical gout and chronic gouty arthritis

Clinical and Mechanism Study on Qifu Huazhuo Formula in Treating intercritical gout and chronic gouty arthritis

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073188
Enrollment
Unknown
Registered
2023-07-04
Start date
2023-07-06
Completion date
Unknown
Last updated
2023-07-10

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

Conditions

gout

Interventions

Traditional Chinese Medicine Group:Qifu Huazhuo Formula (250ml/time, twice a day, oral)
Traditional Chinese add Western Medicine Group:Febuxostat (40mg/dose, once daily, oral)+Qifu Huazhuo Formula (250ml/dose, twice daily, oral)
Western Medicine Group:Febuxostat (40mg/dose, once daily, oral)

Sponsors

Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria of traditional Chinese and Western medicine for intercritical gout and chronic gouty arthritis; (2) During the screening period, the uric acid level is higher than 420 µ mol/L; (3) Men or women aged 18-65; (4) Sign an informed consent form and be able to adhere to the research visit schedule.

Exclusion criteria

Exclusion criteria: (1) Patients with cardiovascular diseases such as coronary heart disease, heart failure, and arrhythmia; (2) Have a history of allergies to relevant experimental drugs (including experimental drugs, control drugs, etc.); (3) The ALT value during the screening period is greater than 1.5 times the upper limit of the normal value; (4) During the screening period, blood creatinine140/90mmHg), poor blood glucose control (HbA1c>7%), and poor blood lipid control (total cholesterol>5.2 mmol/L, triglycerides>1.7 mmol/L); (11) Patients who are using thioprine or azathioprine; (12) The physician's evaluation and judgment may cause interference with the experimental results; (For example, individuals with clear hematological disorders, malignant tumors, steroid therapy, mental illness, or drug or other substance abuse;)

Design outcomes

Primary

MeasureTime frame
The percent change in serum uric acid from baseline at final visit;

Secondary

MeasureTime frame
Changes in ultrasound imaging from baseline at final visit;Changes in glomerular filtration rate from baseline at final visit;Number of gout flares during treatment;Patient outcome report scale from baseline at final visit;Scoring of core syndrome information collection and representation of dampness syndrome in traditional Chinese medicine from baseline at final visit;

Countries

China

Contacts

Public ContactZhengdong Shen

Zhuhai Branch of Guangdong Provincial Hospital of Chinese Medicine

oritentdong@163.com+86 185 1317 3077

Outcome results

None listed

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