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临床试验/NCT04480359
NCT04480359Unknown2 期

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

Shanghai University of Traditional Chinese Medicine1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2017年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
发起方
入组人数
80
试验地点
1
主要终点
Range of motion

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

Bawei Shenqi group

Active Comparator

participants should administrate both Bawei Shenqi Pill and Meloxicam tablets

干预措施: Bawei Shenqi Pill (Drug)

Bawei Shenqi group

Active Comparator

participants should administrate both Bawei Shenqi Pill and Meloxicam tablets

干预措施: Meloxicam (Drug)

placebo group

Placebo Comparator

participants should administrate both Bawei Shenqi Pill placebo and Meloxicam tablets

干预措施: Bawei Shenqi Pill placebo (Drug)

placebo group

Placebo Comparator

participants should administrate both Bawei Shenqi Pill placebo and Meloxicam tablets

干预措施: Meloxicam (Drug)

结局指标

主要结局

Range of motion

时间窗: 12weeks

occipital wall distance, chest expansion distance, finger ground distance, Schober test

BASFI

时间窗: 12weeks

Bath Ankylosing Spondylitis Functional Index

CRP

时间窗: 12weeks

C-reactive protein

ESR

时间窗: 12weeks

Erythrocyte sedimentation rate

BASDAI

时间窗: 12weeks

Bath Ankylosing Spondylitis Disease Activity Index

次要结局

  • SF-36(at baseline and at 3 months)

研究者

发起方
Shanghai University of Traditional Chinese Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

maojianchun

professor

Shanghai University of Traditional Chinese Medicine

研究点 (1)

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