Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2025-12-24 @ 2:59 PM
NCT ID:
NCT04934059
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04934059
Study Brief:
Protocol Section:
NCT04934059