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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ankylosing Spondylitis
• Intervention / Treatment: Drug: Yuxuebi tablet; Drug: Placebo tablet

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Guang'anmen hospital
    • Contact: Quan Jiang
  • Guangzhou, China
    • The first People's Hospital of Guangzhou
    • Contact: Xiaoyan Cai
  • Jinzhong, China
    • The First People's Hospital of Jinzhong
  • Nanchong, China
    • Nanchong Central Hospital
    • Contact: Shiquan Shuai
  • Shenzhen, China
    • Shenzhen Traditional Chinese Medicine Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Yuxuebi tablet; take 5 tablets once, 3 times a day, for 42（±3）days.	Drug: Yuxuebi tablet; 0.5g/ tablet
PLACEBO_COMPARATOR: Placebo tablet; take 5 tablets once, 3 times a day, for 42（±3）days.	Drug: Placebo tablet; 0.5g/ tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Visual analogue scale (VAS) for night pain	Baseline, at day 7, day 14, day 28, day 42 during treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The Evaluation Scale of Syndrome score ranges from 0 (best score) to 15 (worst score).	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
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

Collaborators and Investigators

• Sponsor: China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2021
• Primary Completion (ANTICIPATED): January 31, 2022
• Study Completion (ANTICIPATED): January 31, 2022

Study Registration Dates

• First Submitted: June 8, 2021
• First Submitted That Met QC Criteria: June 14, 2021
• First Posted (ACTUAL): June 22, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 22, 2021
• Last Update Submitted That Met QC Criteria: June 14, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Spondylarthropathies; Bone Diseases, Infectious; Ankylosis; Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
• Other Study ID Numbers: 2020005P8A02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No