Efficacy and Safety of Yuxuebi Tablet in Treating Night Pain of Ankylosing Spondylitis (AS).
- Registration Number
- NCT04934059
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Yuxuebi tablet Yuxuebi tablet take 5 tablets once, 3 times a day, for 42（±3）days. Placebo tablet Placebo tablet take 5 tablets once, 3 times a day, for 42（±3）days.
- Primary Outcome Measures
Name Time Method Change in Visual analogue scale (VAS) for night pain Baseline, at day 7, day 14, day 28, day 42 during treatment
- Secondary Outcome Measures
Name Time Method Visual analogue scale (VAS) for whole day Baseline, at day 7, day 14, day 28, 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 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 The Evaluation Scale of Syndrome score ranges from 0 (best score) to 15 (worst score).
SF-36 (The Medical Outcomes Study 36-item short-form health survey) Baseline, at day 42 during treatment
Trial Locations
- Locations (5)
The First People's Hospital of Jinzhong
🇨🇳Jinzhong, China
Nanchong Central Hospital
🇨🇳Nanchong, China
Guang'anmen Hospital
🇨🇳Beijing, China
The First People's Hospital of Guangzhou
🇨🇳Guangzhou, China
Shenzhen Traditional Chinese Medicine Hospital
🇨🇳Shenzhen, China