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.

China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.5 sites in 1 country60 target enrollmentJuly 1, 2021

ConditionsAnkylosing Spondylitis

InterventionsYuxuebi tablet Placebo tablet

DrugsYuxuebi tablet Placebo tablet

Overview

Phase: Phase 4
Intervention: Yuxuebi tablet
Conditions: Ankylosing Spondylitis
Sponsor: China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.
Enrollment: 60
Locations: 5
Primary Endpoint: Change in Visual analogue scale (VAS) for night pain
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 1, 2021

End Date

January 31, 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Yuxuebi tablet

take 5 tablets once, 3 times a day, for 42（±3）days.

Intervention: Yuxuebi tablet

Placebo tablet

take 5 tablets once, 3 times a day, for 42（±3）days.

Intervention: Placebo tablet

Outcomes

Primary Outcomes

Change in Visual analogue scale (VAS) for night pain

Time Frame: Baseline, at day 7, day 14, day 28, day 42 during treatment

Secondary Outcomes

ESR (Erythrocyte Sedimentation Rate)(Baseline, at day 14, 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)
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)
SF-36 (The Medical Outcomes Study 36-item short-form health survey)(Baseline, at day 42 during treatment)