Ankylosing Spondylitis
Conditions
Brief 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.
Interventions
DRUGYuxuebi tablet
0.5g/ tablet
DRUGPlacebo tablet
0.5g/ tablet
Sponsors
China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Visual analogue scale (VAS) for night pain | Baseline, at day 7, day 14, day 28, day 42 during treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Visual analogue scale (VAS) for whole day | Baseline, at day 7, day 14, 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 | — |
| Syndrome score of traditional Chinese medicine | Baseline, at day 28, day 42 during treatment | The Evaluation Scale of Syndrome score ranges from 0 (best score) to 15 (worst score). |
Countries
China
Outcome results
None listed