Efficacy and Safety of Yuxuebi Tablet in Treating Night Pain of Ankylosing Spondylitis (AS).

Ankylosing Spondylitis Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04934059
• Other study ID #: 2020005P8A02
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 1, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: June 2021
• Source: China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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?

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.

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• Yuxuebi tablet
0.5g/ tablet
• Placebo tablet
0.5g/ tablet

Locations

Country	Name	City	State
China	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

Sponsors (1)

Lead Sponsor	Collaborator
China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Visual analogue scale (VAS) for night pain		Baseline, at day 7, day 14, day 28, day 42 during treatment
Secondary	Visual analogue scale (VAS) for whole day		Baseline, at day 7, day 14, day 28, day 42 during treatment
Secondary	BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)		Baseline, at day 28, day 42 during treatment
Secondary	BASFI (Bath Ankylosing Spondylitis Functional Index)		Baseline, at day 28, day 42 during treatment
Secondary	BASMI (Bath Ankylosing Spondylitis Metrology Index)		Baseline, at day 28, day 42 during treatment
Secondary	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
Secondary	SF-36 (The Medical Outcomes Study 36-item short-form health survey)		Baseline, at day 42 during treatment
Secondary	ESR (Erythrocyte Sedimentation Rate)		Baseline, at day 14, day 28, day 42 during treatment
Secondary	CRP (C-Reactive Protein)		Baseline, at day 14, day 28, day 42 during treatment