A Clinical Trial About the Efficacy and Safety of HuZhen Capsule in Treating Patients With Acute Gout: A 72 Hours, Multi-center, Randomized, Double-blind, Parallel Placebo Compared Clinical Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Change of VAS (visual analog scale) score from baseline to 72 Hours after onset
研究概览
简要总结
This study is a multi-center, double-blind, randomized, parallel controlled trial. Patients with acute gout will be enrolled and randomly allocated into 2 groups: HuZhen capsule treatment group and Placebo control group. Randomization codes were established by the biostatistician. Observe will be followed for 3 days (72 hours) after the onset. Change of VAS score from baseline, proportion of improvement with damp-heat retention, change in C-reactive protein (CRP) and erythrocyte sedimentation rate ( ESR) from baseline, change in white blood cell count in whole blood cell analysis from baseline, and the number of adverse events will be monitored and compared between each groups.
详细描述
The test group will be given HuZhen capsule 1.6g three times per day,the control group will be given placebo 1.6g three times per day. The invention will last 3 days.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Score is equal to or larger than 40cm on the 0-100cm VAS pain scale.
- •Acute attack of gout no longer than 2 days.
- •Participant with acute gout is diagnosed as "damp-heat retention" by Traditional Chinese medicine.
- •Age 18-65 years with informed consent.
排除标准
- •Chronic gouty arthritis.
- •Pseudogout, acute rheumatic fever and suppurative arthritis, traumatic arthritis, erysipelas, meander rheumatism and other arthritis.
- •Anti-inflammatory medication for the treatment of acute gout.
- •Pregnant or breastfeeding women.
- •History of severe allergy, including diclofenac sodium.
- •Serum creatinine is higher than the upper normal limit. ALT or AST is higher than the upper normal limit for two times.
- •Fever ( T>38.5 ℃)
研究组 & 干预措施
HuZhen Capsule
The main elements of HuZhen Capsule include Polygonum cuspidatum, Ligustrum lucidum etc.
干预措施: HuZhen Capsule (Drug)
Placebo Capsule
Placebo appearance, content color and taste should be consistent with HuZhen Capsule.
干预措施: Placebo Capsule (Drug)
结局指标
主要结局
Change of VAS (visual analog scale) score from baseline to 72 Hours after onset
时间窗: baseline,72 hours
次要结局
- The number of adverse events related to treatment(72 hours)
- Change in white blood cell count in whole blood cell analysis from baseline to 72 hours(baseline,72 hours)
- Change in C-reactive protein (CRP) from baseline to 72 hours(baseline,72 hours)
- Change in erythrocyte sedimentation rate ( ESR) from baseline to 72 hours(baseline,72 hours)
- Proportion of participants with improvement in acute gout at 72 hours post-dose using the criteria for the diagnosis of damp-heat retention(72 hours)
研究者
Quan Jiang
Director and Professor of Rheumatology Devision
Guang'anmen Hospital of China Academy of Chinese Medical Sciences