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

• Status: Not yet recruiting
• Trial end date: 2022-01-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.

Criteria

Inclusion Criteria:

1. Ages 18-65, male or female

2. Confirmed diagnosis of Ankylosing Spondylitis

3. Syndrome of traditional Chinese medicine is blood stasis syndrome

4. ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score)≥2.1

5. Visual analogue scale (VAS) for night pain≥4分

6. Maintained stable doses of Sulfasalazine, Methotrexate, Leflunomide, etc. for more than 1 month if treating with Slow-Acting Antirheumatic Drugs

7. Maintained stable doses of biologics for more than 3 month if treating with biologics

8. Not use Nonsteroidal Antiinflammatory Drugs within 2 weeks

9. Patients who have not participated in other clinical trials within 4 weeks

10. Written informed consent

Exclusion Criteria:

1. Pregnant or breastfeeding or who expecting to conceive

2. Psoriatic arthritis or Enteropathic arthritis

3. AS with iritis or uveitis

4. Abnormal liver function

5. Abnormal kidney function，high level of Creatinine

6. WBC (White Blood Cell)<3.0×10^9/L or with Hematological Disease

7. Patients with poor control of hypertension or diabetes

8. Acute or chronic infectious diseases

9. Severe arrhythmia

10. Patients with malignant tumors or with a history of malignant tumors

11. Drug allergy

12. Patients who had taken Yuxuebi tablet for more than 4 weeks with poor outcome

13. Patients who are treating with Traditional Chinese medicine for promoting blood circulation and removing blood stasis

14. Alcohol or drug abuse

15. Participants who are not suitable for clinical trial under doctors' consideration.