Clinical trial NCT04934059: Efficacy and Safety of Yuxuebi Tablet in Treating Night Pain of Ankylosing Spondylitis (AS).
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Ankylosing Spondylitis
Lead sponsor: China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-06-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change in Visual analogue scale (VAS) for night pain
timeFrame: Baseline, at day 7, day 14, day 28, day 42 during treatment
Secondary outcomes:
measure: Visual analogue scale (VAS) for whole day
timeFrame: Baseline, at day 7, day 14, day 28, day 42 during treatment
measure: BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)
timeFrame: Baseline, at day 28, day 42 during treatment
measure: BASFI (Bath Ankylosing Spondylitis Functional Index)
timeFrame: Baseline, at day 28, day 42 during treatment
measure: BASMI (Bath Ankylosing Spondylitis Metrology Index)
timeFrame: Baseline, at day 28, day 42 during treatment
measure: Syndrome score of traditional Chinese medicine
timeFrame: Baseline, at day 28, day 42 during treatment
measure: SF-36 (The Medical Outcomes Study 36-item short-form health survey)
timeFrame: Baseline, at day 42 during treatment
measure: ESR (Erythrocyte Sedimentation Rate)
timeFrame: Baseline, at day 14, day 28, day 42 during treatment
measure: CRP (C-Reactive Protein)
timeFrame: Baseline, at day 14, day 28, day 42 during treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospital
city: Guangzhou
country: China
facility: The First People's Hospital of Guangzhou
city: Jinzhong
country: China
facility: The First People's Hospital of Jinzhong
city: Nanchong
country: China
facility: Nanchong Central Hospital
city: Shenzhen
country: China
facility: Shenzhen Traditional Chinese Medicine Hospital
Study officials:
References: