Bawei Shenqi Pill in the Treatment of Ankylosing Spondylitis

The Clinical Research of the Traditional Chinese Medicine Bawei Shenqi Pill in the Treatment of the Kidney Yang Deficiency Type of Ankylosing Spondylitis

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

Study Overview

• Status: Unknown
• Conditions: Ankylosing Spondylitis
• Intervention / Treatment: Drug: Bawei Shenqi Pill; Drug: Meloxicam; Drug: Bawei Shenqi Pill placebo

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Jianchun Mao, master; Phone Number: 86-18917763231; Email: mjcct2018@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Recruiting
      • Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine
      • Contact: Jianchun Mao, master; Phone Number: 86-18917763231; Email: mjcct2018@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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: Meloxicam; 7.5mg, once a day, 3 month, oral; Other Names: Experimental:Bawei Shenqi group; Placebo Comparator: placebo group; Drug: Bawei Shenqi Pill placebo; 5.1g, once a day, 3month, oral; 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

Collaborators and Investigators

• Sponsor: Shanghai University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Anticipated): August 30, 2020
• Study Completion (Anticipated): September 30, 2020

Study Registration Dates

• First Submitted: July 16, 2020
• First Submitted That Met QC Criteria: July 18, 2020
• First Posted (Actual): July 21, 2020

Study Record Updates

• Last Update Posted (Actual): August 14, 2020
• Last Update Submitted That Met QC Criteria: August 13, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: clinical research; ankylosing spondylitis; Bawei Shenqi Pill
• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Spondylarthropathies; Bone Diseases, Infectious; Ankylosis; Spondylitis; Spondylarthritis; Spondylitis, Ankylosing; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Meloxicam
• Other Study ID Numbers: Bawei Shenqi Pill

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No