Bawei Shenqi Pill in the Treatment of Ankylosing Spondylitis

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.

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

Conditions
-----------------
Ankylosing Spondylitis

Intervention / Treatment
-----------------
* Drug: Bawei Shenqi Pill
* Drug: Bawei Shenqi Pill placebo
* Drug: Meloxicam


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bawei Shenqi group<br>participants should administrate both Bawei Shenqi Pill and Meloxicam tablets | Drug: Bawei Shenqi Pill<br>* 5.1g, once a day, 3month, oral<br>* Other names: Experimental:Bawei Shenqi group;Drug: Meloxicam<br>* 7.5mg, once a day, 3 month, oral<br>* Other names: Placebo Comparator: placebo group;|
| Placebo Comparator: placebo group<br>participants should administrate both Bawei Shenqi Pill placebo and Meloxicam tablets | Drug: Bawei Shenqi Pill placebo<br>* 5.1g, once a day, 3month, oral<br>* Other names: Placebo Comparator: placebo group;Drug: Meloxicam<br>* 7.5mg, once a day, 3 month, oral<br>* Other names: Placebo Comparator: placebo group;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-36 | SF- 36 scale for quality of life assessment | at baseline and at 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bawei Shenqi Pill, ankylosing spondylitis, clinical research