Status:
RECRUITING
A Study to Evaluate Efficacy and Safety of Qingzhu Granules in the Treatment of Acute Gouty Arthritis
Lead Sponsor:
Tasly Pharmaceutical Group Co., Ltd
Conditions:
Gouty Arthritis
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
This study will evaluate the efficacy and safety of Qingzhu Granules in the treatment of Acute Gouty Arthritis ( Damp heat pattern)
Eligibility Criteria
Inclusion
- Male and female patients aged 18 to 70 years.
- Patient meeting the ACR/ EULAR 2015 gout classification criteria.
- Patient meeting the Damp heat Pattern identification of the traditional Chinese medicine.
- Onset of current flare within 48 hours.
- Patient-reported, current ongoing flare of gouty arthritis characterized by baseline pain intensity in the index joint of ≥40 mm on a 0-100 mm VAS.
- Signed informed consent to participate in this study.
Exclusion
- Secondary gouty arthritis ( caused by other diseases or drugs).
- The presence of pain symptoms caused by other diseases, as judged by the investigator, may have an impact on the safety or effectiveness evaluation.
- If there are severe motor, digestive, respiratory, urological, reproductive, endocrine, immune, neurological, circulatory, or psychiatric disorders, the investigator may determine that it may have an impact on the safety or effectiveness evaluation.
- Abnormal liver function (glutamic-oxaloacetic transaminase or glutamic-pyruvic transaminase\>2 ULN) or abnormal renal function (blood creatinine\>ULN).
- People who are not eligible for VAS evaluation, such as those with severe impairment of abstract ability, visual and writing function, and those who have taken sedatives.
- Patients who have undergone uric acid lowering treatment but have not stably used uric acid lowering drugs within the 2 weeks prior to randomization.
- After this gout attack, traditional Chinese medicine, chemical drugs (including but not limited to colchicine, glucocorticoids, and adrenocorticotropins), biological drugs (including but not limited to IL-1 and TNF- α Inhibitor) ,and non drug treatment (including but not limited to acupuncture and moxibustion and topical ice)that have therapeutic effects on gout have been used.
- After this gout attack, non-steroidal anti-inflammatory drugs (including but not limited to aspirin, acetaminophen, losoprofen, ibuprofen, and diclofenac sodium) have been used, and the medication duration is within 5 half-lives of the drug.
- Known allergies to the drug components of this study.
- Contraindications to diclofenac sodium enteric coated tablets.
- Men or women who have plans for conception within 3 months after the start to the end of the study.
- Pregnant and lactating women.
- Participated in other clinical trials within the past month.
- Other situations that the investigator determines are not suitable for enrollment.
Key Trial Info
Start Date :
November 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
472 Patients enrolled
Trial Details
Trial ID
NCT06068478
Start Date
November 7 2023
End Date
October 1 2025
Last Update
June 3 2025
Active Locations (29)
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1
Henan Province Luoyang Orthopedic Hospital
Luoyang, Henan, China
2
Xinxiang Central Hospital
Xinxiang, Henan, China
3
Guang'anmen Hospital of the Chinese Academy of Traditional Chinese Medicine
Beijing, China
4
Binzhou Medical College Affiliated Hospital
Binzhou, China