NCT04934059Unknown4 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Yuxuebi Tablet in Treating Night Pain of Ankylosing Spondylitis.
China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.5 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年7月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 5
- 主要终点
- Change in Visual analogue scale (VAS) for night pain
研究概览
简要总结
This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of Yuxuebi tablet in treating night pain of Ankylosing Spondylitis.
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
- •Ages 18-65, male or female
- •Confirmed diagnosis of Ankylosing Spondylitis
- •Syndrome of traditional Chinese medicine is blood stasis syndrome
- •ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score)≥2.1
- •Visual analogue scale (VAS) for night pain≥4 分
- •Maintained stable doses of Sulfasalazine, Methotrexate, Leflunomide, etc. for more than 1 month if treating with Slow-Acting Antirheumatic Drugs
- •Maintained stable doses of biologics for more than 3 month if treating with biologics
- •Not use Nonsteroidal Antiinflammatory Drugs within 2 weeks
- •Patients who have not participated in other clinical trials within 4 weeks
- •Written informed consent
排除标准
- •Pregnant or breastfeeding or who expecting to conceive
- •Psoriatic arthritis or Enteropathic arthritis
- •AS with iritis or uveitis
- •Abnormal liver function
- •Abnormal kidney function，high level of Creatinine
- •WBC (White Blood Cell)<3.0×10^9/L or with Hematological Disease
- •Patients with poor control of hypertension or diabetes
- •Acute or chronic infectious diseases
- •Severe arrhythmia
- •Patients with malignant tumors or with a history of malignant tumors
- •Drug allergy
- •Patients who had taken Yuxuebi tablet for more than 4 weeks with poor outcome
- •Patients who are treating with Traditional Chinese medicine for promoting blood circulation and removing blood stasis
- •Alcohol or drug abuse
- •Participants who are not suitable for clinical trial under doctors' consideration.
研究组 & 干预措施
Yuxuebi tablet
Experimental
take 5 tablets once, 3 times a day, for 42（±3）days.
干预措施: Yuxuebi tablet (Drug)
Placebo tablet
Placebo Comparator
take 5 tablets once, 3 times a day, for 42（±3）days.
干预措施: Placebo tablet (Drug)
结局指标
主要结局
Change in Visual analogue scale (VAS) for night pain
时间窗: Baseline, at day 7, day 14, day 28, day 42 during treatment
次要结局
- ESR (Erythrocyte Sedimentation Rate)(Baseline, at day 14, day 28, day 42 during treatment)
- Visual analogue scale (VAS) for whole day(Baseline, at day 7, day 14, day 28, day 42 during treatment)
- CRP (C-Reactive Protein)(Baseline, at day 14, day 28, day 42 during treatment)
- BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)(Baseline, at day 28, day 42 during treatment)
- BASFI (Bath Ankylosing Spondylitis Functional Index)(Baseline, at day 28, day 42 during treatment)
- BASMI (Bath Ankylosing Spondylitis Metrology Index)(Baseline, at day 28, day 42 during treatment)
- Syndrome score of traditional Chinese medicine(Baseline, at day 28, day 42 during treatment)
- SF-36 (The Medical Outcomes Study 36-item short-form health survey)(Baseline, at day 42 during treatment)
研究者
研究点 (5)
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