Efficacy and Safety of Yuxuebi Tablet in Treating Night Pain of Ankylosing Spondylitis (AS).
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.
1 other identifier
interventional
60
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jul 2021
Shorter than P25 for phase_4
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2021
CompletedFirst Posted
Study publicly available on registry
June 22, 2021
CompletedStudy Start
First participant enrolled
July 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2022
CompletedJune 22, 2021
June 1, 2021
7 months
June 8, 2021
June 14, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Visual analogue scale (VAS) for night pain
Baseline, at day 7, day 14, day 28, day 42 during treatment
Secondary Outcomes (8)
Visual analogue scale (VAS) for whole day
Baseline, at day 7, 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
- +3 more secondary outcomes
Study Arms (2)
Yuxuebi tablet
EXPERIMENTALtake 5 tablets once, 3 times a day, for 42（±3）days.
Placebo tablet
PLACEBO COMPARATORtake 5 tablets once, 3 times a day, for 42（±3）days.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Guang'anmen Hospital
Beijing, China
The First People's Hospital of Guangzhou
Guangzhou, China
The First People's Hospital of Jinzhong
Jinzhong, China
Nanchong Central Hospital
Nanchong, China
Shenzhen Traditional Chinese Medicine Hospital
Shenzhen, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2021
First Posted
June 22, 2021
Study Start
July 1, 2021
Primary Completion
January 31, 2022
Study Completion
January 31, 2022
Last Updated
June 22, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share