A Phase 2/3 interventional study of Bawei Shenqi Pill and Bawei Shenqi Pill placebo in Ankylosing Spondylitis, sponsored by Shanghai University of Traditional Chinese Medicine. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-08-14.
Sponsored by Shanghai University of Traditional Chinese Medicine · Phase 2/3, Interventional, and Treatment
The purpose of this study is to determine whether Bawei Shenqi Pill is effective in the treatment of active ankylosing spondylitis (AS).
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.
623 studies on the registry are indexed under Spondylitis; 83 are open to participants now.
This study's planned enrollment of 80 is below the median of 92 across 349 interventional studies indexed under Spondylitis.
Browse Spondylitis studies →Shanghai University of Traditional Chinese Medicine is the lead sponsor of 99 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
participants should administrate both Bawei Shenqi Pill and Meloxicam tablets
Drug: Bawei Shenqi Pill · Drug: Meloxicam
participants should administrate both Bawei Shenqi Pill placebo and Meloxicam tablets
Drug: Bawei Shenqi Pill placebo · Drug: Meloxicam
5.1g, once a day, 3month, oral
Also known as: Experimental:Bawei Shenqi group
5.1g, once a day, 3month, oral
Also known as: Placebo Comparator: placebo group
7.5mg, once a day, 3 month, oral
Also known as: Experimental:Bawei Shenqi group, Placebo Comparator: placebo group
BASDAI
Bath Ankylosing Spondylitis Disease Activity Index
Time frame: 12weeks
BASFI
Bath Ankylosing Spondylitis Functional Index
Time frame: 12weeks
CRP
C-reactive protein
Time frame: 12weeks
ESR
Erythrocyte sedimentation rate
Time frame: 12weeks
Range of motion
occipital wall distance, chest expansion distance, finger ground distance, Schober test
Time frame: 12weeks
SF-36
SF- 36 scale for quality of life assessment
Time frame: at baseline and at 3 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Shanghai University of Traditional Chinese Medicine