Efficacy and Safety of Yuxuebi Tablet in Treating Night Pain of Ankylosing Spondylitis (AS).

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Ankylosing Spondylitis

Intervention / Treatment
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* Drug: Yuxuebi tablet
* Drug: Placebo tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yuxuebi tablet<br>take 5 tablets once, 3 times a day, for 42（±3）days. | Drug: Yuxuebi tablet<br>* 0.5g/ tablet<br>|
| Placebo Comparator: Placebo tablet<br>take 5 tablets once, 3 times a day, for 42（±3）days. | Drug: Placebo tablet<br>* 0.5g/ tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual analogue scale (VAS) for night pain |  | Baseline, at day 7, day 14, day 28, day 42 during treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale (VAS) for whole day |  | Baseline, at day 7, 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 | The Evaluation Scale of Syndrome score ranges from 0 (best score) to 15 (worst score). | 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 | 
| ESR (Erythrocyte Sedimentation Rate) |  | Baseline, at day 14, day 28, day 42 during treatment | 
| CRP (C-Reactive Protein) |  | Baseline, at day 14, day 28, day 42 during treatment |