NCT06068478招募中3 期
A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Clinical Trial, Efficacy and Safety Study of Qingzhu Granules in the Treatment of Acute Gouty Arthritis ( Damp Heat Pattern)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 472
- 试验地点
- 29
- 主要终点
- Visual Analogue Score (VAS)
研究概览
简要总结
This study will evaluate the efficacy and safety of Qingzhu Granules in the treatment of Acute Gouty Arthritis ( Damp heat pattern)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Qingzhu Granules
Experimental
干预措施: Qingzhu Granules (Drug)
Qingzhu Granules Placebo
Placebo Comparator
干预措施: Qingzhu Granules Placebo (Drug)
结局指标
主要结局
Visual Analogue Score (VAS)
时间窗: 72 hours
Change from basline in Patient-assessed Pain Intensity on VAS at 72 hours after the investigational product therapy.
次要结局
- Visual Analogue Score (VAS)(24/48 hours)
- The total score of the Traditional Chinese Medicine Syndrome(72 hours)
- The each item score of the Traditional Chinese Medicine Syndrome(72 hours)
- Rescue medication(72 hours)
- CRP(72 hours)
- Time interval(72 hours)
研究者
研究点 (29)
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