Juanbi Pill for Rheumatoid Arthritis

Last updated: July 13, 2018
Sponsor: Cui xuejun
Overall Status: Active - Recruiting

Phase

2/3

Condition

Rheumatoid Arthritis

Arthritis And Arthritic Pain

Bone Diseases

Treatment

N/A

Clinical Study ID

NCT02885597
Juanbi pill
  • Ages 18-80
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults with rheumatoid arthritis (score more then 5 of ACR (American College OfRheumatology) /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 morethan 10mg oral glucocorticoids or biologic agents

  • paid employment or unpaid but measurable work (e.g., caring for a family and home)

Exclusion

Exclusion Criteria:

  • 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

Study Design

Total Participants: 120
Study Start date:
July 01, 2018
Estimated Completion Date:
December 31, 2020

Study Description

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.

Connect with a study center

  • Longhua Hospital, Shanghai University of TCM

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

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