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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
Sponsor:
Information provided by (Responsible Party):
maojianchun, Shanghai University of Traditional Chinese Medicine

Study Description
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Brief Summary:
The purpose of this study is to determine whether Bawei Shenqi Pill is effective in the treatment of active ankylosing spondylitis (AS).

Condition or disease Intervention/treatment Phase
Ankylosing Spondylitis Drug: Bawei Shenqi Pill Drug: Bawei Shenqi Pill placebo Drug: Meloxicam Phase 2 Phase 3

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
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Meloxicam

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Bawei Shenqi group
participants should administrate both Bawei Shenqi Pill and Meloxicam tablets
 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:
  • Experimental:Bawei Shenqi group
  • Placebo Comparator: placebo group
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:
  • Experimental:Bawei Shenqi group
  • Placebo Comparator: placebo group


Outcome Measures
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Primary Outcome Measures :
  1. BASDAI [ Time Frame: 12weeks ]
    Bath Ankylosing Spondylitis Disease Activity Index

  2. BASFI [ Time Frame: 12weeks ]
    Bath Ankylosing Spondylitis Functional Index

  3. CRP [ Time Frame: 12weeks ]
    C-reactive protein

  4. ESR [ Time Frame: 12weeks ]
    Erythrocyte sedimentation rate

  5. Range of motion [ Time Frame: 12weeks ]
    occipital wall distance, chest expansion distance, finger ground distance, Schober test


Secondary Outcome Measures :
  1. SF-36 [ Time Frame: at baseline and at 3 months ]
    SF- 36 scale for quality of life assessment


Eligibility Criteria
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Information from the National Library of Medicine

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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
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Jianchun Mao, master 86-18917763231 mjcct2018@163.com

Locations
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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   
Sponsors and Collaborators
Shanghai University of Traditional Chinese Medicine
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by maojianchun, Shanghai University of Traditional Chinese Medicine:
Bawei Shenqi Pill
ankylosing spondylitis
clinical research
Additional relevant MeSH terms:
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Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
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