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

Primary Purpose

Ankylosing Spondylitis

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Yuxuebi tablet
Placebo tablet
Sponsored by
China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankylosing Spondylitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Guang'anmen Hospital
  • The First People's Hospital of Guangzhou
  • The First People's Hospital of Jinzhong
  • Nanchong Central Hospital
  • Shenzhen Traditional Chinese Medicine Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Yuxuebi tablet

Placebo tablet

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in Visual analogue scale (VAS) for night pain

Secondary Outcome Measures

Visual analogue scale (VAS) for whole day
BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)
BASFI (Bath Ankylosing Spondylitis Functional Index)
BASMI (Bath Ankylosing Spondylitis Metrology Index)
Syndrome score of traditional Chinese medicine
The Evaluation Scale of Syndrome score ranges from 0 (best score) to 15 (worst score).
SF-36 (The Medical Outcomes Study 36-item short-form health survey)
ESR (Erythrocyte Sedimentation Rate)
CRP (C-Reactive Protein)

Full Information

First Posted
June 8, 2021
Last Updated
June 14, 2021
Sponsor
China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04934059
Brief Title
Efficacy and Safety of Yuxuebi Tablet in Treating Night Pain of Ankylosing Spondylitis (AS).
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2021 (Anticipated)
Primary Completion Date
January 31, 2022 (Anticipated)
Study Completion Date
January 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Yuxuebi tablet
Arm Type
Experimental
Arm Description
take 5 tablets once, 3 times a day, for 42（±3）days.
Arm Title
Placebo tablet
Arm Type
Placebo Comparator
Arm Description
take 5 tablets once, 3 times a day, for 42（±3）days.
Intervention Type
Drug
Intervention Name(s)
Yuxuebi tablet
Intervention Description
0.5g/ tablet
Intervention Type
Drug
Intervention Name(s)
Placebo tablet
Intervention Description
0.5g/ tablet
Primary Outcome Measure Information:
Title
Change in Visual analogue scale (VAS) for night pain
Time Frame
Baseline, at day 7, day 14, day 28, day 42 during treatment
Secondary Outcome Measure Information:
Title
Visual analogue scale (VAS) for whole day
Time Frame
Baseline, at day 7, day 14, day 28, day 42 during treatment
Title
BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)
Time Frame
Baseline, at day 28, day 42 during treatment
Title
BASFI (Bath Ankylosing Spondylitis Functional Index)
Time Frame
Baseline, at day 28, day 42 during treatment
Title
BASMI (Bath Ankylosing Spondylitis Metrology Index)
Time Frame
Baseline, at day 28, day 42 during treatment
Title
Syndrome score of traditional Chinese medicine
Description
The Evaluation Scale of Syndrome score ranges from 0 (best score) to 15 (worst score).
Time Frame
Baseline, at day 28, day 42 during treatment
Title
SF-36 (The Medical Outcomes Study 36-item short-form health survey)
Time Frame
Baseline, at day 42 during treatment
Title
ESR (Erythrocyte Sedimentation Rate)
Time Frame
Baseline, at day 14, day 28, day 42 during treatment
Title
CRP (C-Reactive Protein)
Time Frame
Baseline, at day 14, day 28, day 42 during treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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 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.
Facility Information:
Facility Name
Guang'anmen Hospital
City
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quan Jiang
Facility Name
The First People's Hospital of Guangzhou
City
Guangzhou
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoyan Cai
Facility Name
The First People's Hospital of Jinzhong
City
Jinzhong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tao Jiang
Facility Name
Nanchong Central Hospital
City
Nanchong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shiquan Shuai
Facility Name
Shenzhen Traditional Chinese Medicine Hospital
City
Shenzhen
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianyong Zhang

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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