CompletedPhase 3

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

China472 participantsStarted 2023-11-07

Plain-language summary

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

Who can participate

Age range18 Years – 70 Years

SexALL

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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.

What they're measuring

Visual Analogue Score (VAS)

Timeframe: 72 hours

Trial details

NCT IDNCT06068478

SponsorTasly Pharmaceutical Group Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-04-02

View on ClinicalTrials.gov More Gouty Arthritis trials