Bawei Shenqi Pill in the Treatment of Ankylosing Spondylitis

Ankylosing Spondylitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04480359
• Other study ID #: Bawei Shenqi Pill
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: October 1, 2017
• Est. completion date: September 30, 2020

Study information

• Verified date: July 2020
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: Jianchun Mao, master
• Phone: 86-18917763231
• Email: mjcct2018[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 30, 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• Bawei Shenqi Pill
5.1g, once a day, 3month, oral
• Bawei Shenqi Pill placebo
5.1g, once a day, 3month, oral
• Meloxicam
7.5mg, once a day, 3 month, oral

Locations

Country	Name	City	State
China	Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BASDAI	Bath Ankylosing Spondylitis Disease Activity Index	12weeks
Primary	BASFI	Bath Ankylosing Spondylitis Functional Index	12weeks
Primary	CRP	C-reactive protein	12weeks
Primary	ESR	Erythrocyte sedimentation rate	12weeks
Primary	Range of motion	occipital wall distance, chest expansion distance, finger ground distance, Schober test	12weeks
Secondary	SF-36	SF- 36 scale for quality of life assessment	at baseline and at 3 months