Status:
UNKNOWN
Bawei Shenqi Pill in the Treatment of Ankylosing Spondylitis
Lead Sponsor:
Shanghai University of Traditional Chinese Medicine
Conditions:
Ankylosing Spondylitis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
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 extraar...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2020
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04480359
Start Date
October 1 2017
End Date
September 30 2020
Last Update
August 14 2020
Active Locations (1)
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1
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China, 200030