A Study to Evaluate Efficacy and Safety of Qingzhu Granules in the Treatment of Acute Gouty Arthritis

Inclusion Criteria:

1. Male and female patients aged 18 to 70 years.

2. Patient meeting the ACR/ EULAR 2015 gout classification criteria.

3. Patient meeting the Damp heat Pattern identification of the traditional Chinesemedicine.

4. Onset of current flare within 48 hours.

5. Patient-reported, current ongoing flare of gouty arthritis characterized by baselinepain intensity in the index joint of ≥40 mm on a 0-100 mm VAS.

6. Signed informed consent to participate in this study.

Exclusion Criteria:

1. Secondary gouty arthritis ( caused by other diseases or drugs).

2. The presence of pain symptoms caused by other diseases, as judged by theinvestigator, may have an impact on the safety or effectiveness evaluation.

3. If there are severe motor, digestive, respiratory, urological, reproductive,endocrine, immune, neurological, circulatory, or psychiatric disorders, theinvestigator may determine that it may have an impact on the safety or effectivenessevaluation.

4. Abnormal liver function (glutamic-oxaloacetic transaminase or glutamic-pyruvictransaminase>2 ULN) or abnormal renal function (blood creatinine>ULN).

5. People who are not eligible for VAS evaluation, such as those with severe impairmentof abstract ability, visual and writing function, and those who have takensedatives.

6. Patients who have undergone uric acid lowering treatment but have not stably useduric acid lowering drugs within the 2 weeks prior to randomization.

7. After this gout attack, traditional Chinese medicine, chemical drugs (including butnot limited to colchicine, glucocorticoids, and adrenocorticotropins), biologicaldrugs (including but not limited to IL-1 and TNF- α Inhibitor) ,and non drugtreatment (including but not limited to acupuncture and moxibustion and topicalice)that have therapeutic effects on gout have been used.

8. After this gout attack, non-steroidal anti-inflammatory drugs (including but notlimited to aspirin, acetaminophen, losoprofen, ibuprofen, and diclofenac sodium)have been used, and the medication duration is within 5 half-lives of the drug.

9. Known allergies to the drug components of this study.

10. Contraindications to diclofenac sodium enteric coated tablets.

11. Men or women who have plans for conception within 3 months after the start to theend of the study.

12. Pregnant and lactating women.

13. Participated in other clinical trials within the past month.

14. Other situations that the investigator determines are not suitable for enrollment.