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Bawei Shenqi Pill in the Treatment of Ankylosing Spondylitis

Primary Purpose

Ankylosing Spondylitis

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Bawei Shenqi Pill
Bawei Shenqi Pill placebo
Meloxicam
Sponsored by
Shanghai University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankylosing Spondylitis focused on measuring Bawei Shenqi Pill, ankylosing spondylitis, clinical research

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Compliance with New York standards revised in 1984
  • Syndrome differentiation of traditional Chinese medicine for deficiency of kidney-yang
  • 18 to 70 years of age, male and female
  • Being able to understand or sign an informed consent form

Exclusion Criteria:

  • Other spondyloarthropathy that does not meet the diagnostic criteria of ankylosing spondylitis, and TCM syndrome differentiation does not belong to kidney-yang deficiency type.
  • Age is out of range
  • Do not agree to participate in this topic or can not participate in the whole process
  • Complicated with other rheumatic diseases or other seronegative spondyloarthropathy.
  • Pregnant, lactating women and patients with serious visceral diseases, mental disorders and severe extraarticular manifestations, such as heart, lung, liver, kidney or hematopoietic system.
  • Have had myocardial infarction or stroke, congestive heart failure and active digestive tract ulcer patients.
  • Those who had received other research drugs three months before screening.
  • Inability or unwillingness to provide informed consent or failure to comply with test requirements.
  • The researchers believe that it is not suitable for the owners of the study.

Sites / Locations

  • Longhua Hospital Affiliated to Shanghai University of Traditional Chinese MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Bawei Shenqi group

placebo group

Arm Description

participants should administrate both Bawei Shenqi Pill and Meloxicam tablets

participants should administrate both Bawei Shenqi Pill placebo and Meloxicam tablets

Outcomes

Primary Outcome Measures

BASDAI
Bath Ankylosing Spondylitis Disease Activity Index
BASFI
Bath Ankylosing Spondylitis Functional Index
CRP
C-reactive protein
ESR
Erythrocyte sedimentation rate
Range of motion
occipital wall distance, chest expansion distance, finger ground distance, Schober test

Secondary Outcome Measures

SF-36
SF- 36 scale for quality of life assessment

Full Information

First Posted
July 16, 2020
Last Updated
August 13, 2020
Sponsor
Shanghai University of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04480359
Brief Title
Bawei Shenqi Pill in the Treatment of Ankylosing Spondylitis
Official Title
The Clinical Research of the Traditional Chinese Medicine Bawei Shenqi Pill in the Treatment of the Kidney Yang Deficiency Type of Ankylosing Spondylitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
August 30, 2020 (Anticipated)
Study Completion Date
September 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai University of Traditional Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether Bawei Shenqi Pill is effective in the treatment of active ankylosing spondylitis (AS).
Detailed Description
Ankylosing spondylitis is a chronic inflammatory disease, which mainly invades sacroiliac joint, spinal osteoid process, paraspinal soft tissue and peripheral joints, and can be accompanied by extraarticular manifestations, in severe cases, spinal deformity and ankylosis can occur. The overall prevalence rate of ankylosing spondylitis in China is about 0.3%, the peak of which is 20 to 30 years old. although the prevalence rate is not high, the disability rate is high, and the patients with ankylosing spondylitis are mainly young people of childbearing age, which are in a critical period of work and study. If the disease can not be controlled smoothly, it will seriously affect its learning and work efficiency, image appearance and even the ability of daily life. Bawei Shenqi Pill originates from Zhang Zhongjing's synopsis of the Golden Chamber, is the representative prescription of warming and tonifying kidney yang, and is also suitable for the pathogenesis of ankylosing spondylitis "deficiency of kidney yang". The purpose of this study was to observe the therapeutic effect of Bawei Shenqi Pill on ankylosing spondylitis of kidney-yang deficiency type through a randomized controlled clinical study. To clarify the effect of Bawei Shenqi Pill on disease activity, joint function, TCM syndrome integral and quality of life in patients with ankylosing spondylitis, and to provide basis for the treatment of ankylosing spondylitis with Bawei Shenqi Pill.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis
Keywords
Bawei Shenqi Pill, ankylosing spondylitis, clinical research

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bawei Shenqi group
Arm Type
Active Comparator
Arm Description
participants should administrate both Bawei Shenqi Pill and Meloxicam tablets
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
participants should administrate both Bawei Shenqi Pill placebo and Meloxicam tablets
Intervention Type
Drug
Intervention Name(s)
Bawei Shenqi Pill
Other Intervention Name(s)
Experimental:Bawei Shenqi group
Intervention Description
5.1g, once a day, 3month, oral
Intervention Type
Drug
Intervention Name(s)
Bawei Shenqi Pill placebo
Other Intervention Name(s)
Placebo Comparator: placebo group
Intervention Description
5.1g, once a day, 3month, oral
Intervention Type
Drug
Intervention Name(s)
Meloxicam
Other Intervention Name(s)
Experimental:Bawei Shenqi group, Placebo Comparator: placebo group
Intervention Description
7.5mg, once a day, 3 month, oral
Primary Outcome Measure Information:
Title
BASDAI
Description
Bath Ankylosing Spondylitis Disease Activity Index
Time Frame
12weeks
Title
BASFI
Description
Bath Ankylosing Spondylitis Functional Index
Time Frame
12weeks
Title
CRP
Description
C-reactive protein
Time Frame
12weeks
Title
ESR
Description
Erythrocyte sedimentation rate
Time Frame
12weeks
Title
Range of motion
Description
occipital wall distance, chest expansion distance, finger ground distance, Schober test
Time Frame
12weeks
Secondary Outcome Measure Information:
Title
SF-36
Description
SF- 36 scale for quality of life assessment
Time Frame
at baseline and at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Compliance with New York standards revised in 1984 Syndrome differentiation of traditional Chinese medicine for deficiency of kidney-yang 18 to 70 years of age, male and female Being able to understand or sign an informed consent form Exclusion Criteria: Other spondyloarthropathy that does not meet the diagnostic criteria of ankylosing spondylitis, and TCM syndrome differentiation does not belong to kidney-yang deficiency type. Age is out of range Do not agree to participate in this topic or can not participate in the whole process Complicated with other rheumatic diseases or other seronegative spondyloarthropathy. Pregnant, lactating women and patients with serious visceral diseases, mental disorders and severe extraarticular manifestations, such as heart, lung, liver, kidney or hematopoietic system. Have had myocardial infarction or stroke, congestive heart failure and active digestive tract ulcer patients. Those who had received other research drugs three months before screening. Inability or unwillingness to provide informed consent or failure to comply with test requirements. The researchers believe that it is not suitable for the owners of the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianchun Mao, master
Phone
86-18917763231
Email
mjcct2018@163.com
Facility Information:
Facility Name
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianchun Mao, master
Phone
86-18917763231
Email
mjcct2018@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Bawei Shenqi Pill in the Treatment of Ankylosing Spondylitis

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