Bawei Shenqi Pill in the Treatment of Ankylosing Spondylitis
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ClinicalTrials.gov Identifier: NCT04480359 |
Recruitment Status :
Recruiting
First Posted : July 21, 2020
Last Update Posted : August 14, 2020
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Condition or disease | Intervention/treatment | Phase |
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Ankylosing Spondylitis | Drug: Bawei Shenqi Pill Drug: Bawei Shenqi Pill placebo Drug: Meloxicam | Phase 2 Phase 3 |
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 Type : | Interventional |
Estimated Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | October 1, 2017 |
Estimated Primary Completion Date : | August 30, 2020 |
Estimated Study Completion Date : | September 30, 2020 |

Arm | Intervention/treatment |
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Active Comparator: Bawei Shenqi group
participants should administrate both Bawei Shenqi Pill and Meloxicam tablets
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Drug: Bawei Shenqi Pill
5.1g, once a day, 3month, oral
Other Name: Experimental:Bawei Shenqi group Drug: Meloxicam 7.5mg, once a day, 3 month, oral
Other Names:
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Placebo Comparator: placebo group
participants should administrate both Bawei Shenqi Pill placebo and Meloxicam tablets
|
Drug: Bawei Shenqi Pill placebo
5.1g, once a day, 3month, oral
Other Name: Placebo Comparator: placebo group Drug: Meloxicam 7.5mg, once a day, 3 month, oral
Other Names:
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- BASDAI [ Time Frame: 12weeks ]Bath Ankylosing Spondylitis Disease Activity Index
- BASFI [ Time Frame: 12weeks ]Bath Ankylosing Spondylitis Functional Index
- CRP [ Time Frame: 12weeks ]C-reactive protein
- ESR [ Time Frame: 12weeks ]Erythrocyte sedimentation rate
- Range of motion [ Time Frame: 12weeks ]occipital wall distance, chest expansion distance, finger ground distance, Schober test
- SF-36 [ Time Frame: at baseline and at 3 months ]SF- 36 scale for quality of life assessment

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04480359
Contact: Jianchun Mao, master | 86-18917763231 | mjcct2018@163.com |
China, Shanghai | |
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine | Recruiting |
Shanghai, Shanghai, China, 200030 | |
Contact: Jianchun Mao, master 86-18917763231 mjcct2018@163.com |
Responsible Party: | maojianchun, professor, Shanghai University of Traditional Chinese Medicine |
ClinicalTrials.gov Identifier: | NCT04480359 |
Other Study ID Numbers: |
Bawei Shenqi Pill |
First Posted: | July 21, 2020 Key Record Dates |
Last Update Posted: | August 14, 2020 |
Last Verified: | July 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Bawei Shenqi Pill ankylosing spondylitis clinical research |
Spondylitis Spondylarthritis Spondylitis, Ankylosing Bone Diseases, Infectious Infections Bone Diseases Musculoskeletal Diseases Spinal Diseases Arthritis Joint Diseases Spondylarthropathies Ankylosis Meloxicam |
Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |