The Clinical Research of the Traditional Chinese Medicine Bawei Shenqi Pill in the Treatment of the Kidney Yang Deficiency Type of Ankylosing Spondylitis
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Range of motion
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Bawei Shenqi group
participants should administrate both Bawei Shenqi Pill and Meloxicam tablets
Intervention: Bawei Shenqi Pill (Drug)
Bawei Shenqi group
participants should administrate both Bawei Shenqi Pill and Meloxicam tablets
Intervention: Meloxicam (Drug)
placebo group
participants should administrate both Bawei Shenqi Pill placebo and Meloxicam tablets
Intervention: Bawei Shenqi Pill placebo (Drug)
placebo group
participants should administrate both Bawei Shenqi Pill placebo and Meloxicam tablets
Intervention: Meloxicam (Drug)
Outcomes
Primary Outcomes
Range of motion
Time Frame: 12weeks
occipital wall distance, chest expansion distance, finger ground distance, Schober test
BASFI
Time Frame: 12weeks
Bath Ankylosing Spondylitis Functional Index
CRP
Time Frame: 12weeks
C-reactive protein
ESR
Time Frame: 12weeks
Erythrocyte sedimentation rate
BASDAI
Time Frame: 12weeks
Bath Ankylosing Spondylitis Disease Activity Index
Secondary Outcomes
- SF-36(at baseline and at 3 months)
Investigators
maojianchun
professor
Shanghai University of Traditional Chinese Medicine