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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bawei Shenqi group | Active Comparator | participants should administrate both Bawei Shenqi Pill and Meloxicam tablets |
|
| placebo group | Placebo Comparator | participants should administrate both Bawei Shenqi Pill placebo and Meloxicam tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bawei Shenqi Pill | Drug | 5.1g, once a day, 3month, oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| BASDAI | Bath Ankylosing Spondylitis Disease Activity Index | 12weeks |
| BASFI | Bath Ankylosing Spondylitis Functional Index | 12weeks |
| CRP | C-reactive protein | 12weeks |
| ESR | Erythrocyte sedimentation rate | 12weeks |
| Range of motion | occipital wall distance, chest expansion distance, finger ground distance, Schober test | 12weeks |
| Measure | Description | Time Frame |
|---|---|---|
| SF-36 | SF- 36 scale for quality of life assessment | at baseline and at 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianchun Mao, master | Contact | 86-18917763231 | mjcct2018@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
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| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
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| ID | Term |
|---|---|
| D000077239 | Meloxicam |
| ID | Term |
|---|---|
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D013844 | Thiazoles |
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| Bawei Shenqi Pill placebo | Drug | 5.1g, once a day, 3month, oral |
|
|
| Meloxicam | Drug | 7.5mg, once a day, 3 month, oral |
|
|
| D013122 |
| Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |