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临床试验/NCT02885597
NCT02885597Unknown2 期

Juanbi Pill Combined With Methotrexate for Rheumatoid Arthritis: Multi-center Random Controlled Clinical Trials

Cui xuejun1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年7月最近更新:
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
120
试验地点
1
主要终点
Rate of ACR (American College Of Rheumatology) 50

研究概览

简要总结

The purpose of this study is to determine whether Juanbi Pill combined with methotrexate are effective in the treatment of active Rheumatoid Arthritis (RA).

详细描述

Rheumatoid arthritis patients are suffering from painful and swelling of joints as well as joint destruction and functional disability with the duration of disease activity. Patients and physician try to find a way to alleviate the swell and tenderness of joints to avoid irreversible joints impairment, for evidence indicating that early aggressive treatment results in greater improvement than therapy initiated later in the disease course.

As a complementary and alternative medicine (CAM), herbal medicines have the potential to achieve a clinical remission, or push the disease back to low disease activity. In traditional Chinese medicine (TCM), rheumatoid arthritis is a Bi syndrome and Juanbi decotion (notopterygium root, radix angelicae pubescentis, Gentiana macrophylla, Kadsura Pepper Stem, Mulberry Twig, Angelica sinensis, Ligusticum wallichii, frankincense, Radix Aucklandiae, shaved cinnamon barka and liquorice ) is a medicine specially for Bi syndrome and it has been used in Chinese for hundreds of years. Juanbi pill is the raw extration of Juanbi decotion for the sake of convenience of quality control and storage.

Although the long term usage of Juanbi decotion, there is no high quality evidence about the decotion on rheumatoid arthritis. Using a well-designed clinical trial, the investigators will survey the effectiveness of concurrent use of this decotion in relieving disease activity. Therefore, the present study is to examine effectiveness and safety of Juanbi Pill, a compound traditional Chinese herbal medicine on rheumatoid arthritis in a randomized, double-blind, placebo-controlled trial. Results of this study will provide evidence regarding the value of the Juanbi pill as an intervention to lower the disease activity and protect the affected joints from deformity.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults with rheumatoid arthritis (score more then 5 of ACR (American College Of Rheumatology) /EULAR (European League Against Rheumatism), 2009 )
  • moderate-to-severe disease activity (Disease Activity Score for 28-joint counts (DAS28) of more than 3.2
  • an onset of symptoms within 12 months before enrollment, no prior exposure to more than 10mg oral glucocorticoids or biologic agents
  • paid employment or unpaid but measurable work (e.g., caring for a family and home)

排除标准

  • combined with other disease such as adjuvant arthritis, lupus arthritis, osteoarthritis and et al.
  • abnormal liver and my kidney function
  • pregnancy or have a plan of pregnancy,breast feeding women
  • severe chronic or acute disease interfering with therapy attendance
  • alcohol or substance abuse

研究组 & 干预措施

Juanbi group

Experimental

participants should administrate both Juanbi pill and Methotrexate

干预措施: Juanbi pill (Drug)

Juanbi group

Experimental

participants should administrate both Juanbi pill and Methotrexate

干预措施: Methotrexate (Drug)

placebo group

Placebo Comparator

participants should administrate both Juanbi pill placebo and Methotrexate

干预措施: Juanbi pill placebo (Drug)

placebo group

Placebo Comparator

participants should administrate both Juanbi pill placebo and Methotrexate

干预措施: Methotrexate (Drug)

结局指标

主要结局

Rate of ACR (American College Of Rheumatology) 50

时间窗: at 3 months

changes of The Disease Activity Score (DAS) 28

时间窗: from baseline to 3 months

changes of the van der Heijde modified Sharp score

时间窗: from baseline to 12 months

次要结局

  • change score of Health Assessment Questionnaire - Disability Index(from baseline to 12 months)
  • change score of Patient Global Assessment of Arthritis(from baseline to 12 months)
  • rate of ACR70(at 12 months)
  • Rate of ACR(American College Of Rheumatology)50(at 12 months)
  • change score of 36-item Short-Form Health Survey Questionnaire(form baseline to 12 months)
  • rate of ACR20(12 months)
  • changes of The Disease Activity Score (DAS) 28(from baseline to 12 months)
  • change score of Patient Assessment of Arthritis Pain(from baseline to 12 months)
  • change score of AIS Sleep Scale(from baseline to 12 months)

研究者

发起方
Cui xuejun
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Cui xuejun

Director

Shanghai University of Traditional Chinese Medicine

研究点 (1)

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