Juanbi Pill for Rheumatoid Arthritis
- Conditions
- Rheumatoid ArthritisJuanbi Pill
- Interventions
- Registration Number
- NCT02885597
- Lead Sponsor
- Cui xuejun
- Brief 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).
- Detailed 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
- 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)
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo group Methotrexate participants should administrate both Juanbi pill placebo and Methotrexate placebo group Juanbi pill placebo participants should administrate both Juanbi pill placebo and Methotrexate Juanbi group Juanbi pill participants should administrate both Juanbi pill and Methotrexate Juanbi group Methotrexate participants should administrate both Juanbi pill and Methotrexate
- Primary Outcome Measures
Name Time Method Rate of ACR (American College Of Rheumatology) 50 at 3 months changes of The Disease Activity Score (DAS) 28 from baseline to 3 months changes of the van der Heijde modified Sharp score from baseline to 12 months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Longhua Hospital, Shanghai University of TCM
🇨🇳Shanghai, Shanghai, China