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

Tasly Pharmaceuticals

Status and phase

Enrolling

Phase 3

Conditions

Gouty Arthritis

Treatments

Drug: Qingzhu Granules

Drug: Qingzhu Granules Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT06068478

TSL-TCM-QZKL-Ⅲ

Details and patient eligibility

About

This study will evaluate the efficacy and safety of Qingzhu Granules in the treatment of Acute Gouty Arthritis ( Damp heat pattern)

Enrollment

472 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.