Juanbi Pill for Rheumatoid Arthritis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Juanbi Pill, Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Juanbi pill
* Drug: Juanbi pill placebo
* Drug: Methotrexate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Juanbi group<br>participants should administrate both Juanbi pill and Methotrexate | Drug: Juanbi pill<br>* 4g, twice a day, 3month, oral<br>* Other names: Experimental: Juanbi group;Drug: Methotrexate<br>* 5mg, once a week, 3 month, oral<br>* Other names: Placebo Comparator: placebo group;|
| Placebo Comparator: placebo group<br>participants should administrate both Juanbi pill placebo and Methotrexate | Drug: Juanbi pill placebo<br>* 4g, twice a day, 3month, oral<br>* Other names: Placebo Comparator: placebo group;Drug: Methotrexate<br>* 5mg, once a week, 3 month, oral<br>* Other names: Placebo Comparator: placebo group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of The Disease Activity Score (DAS) 28 |  | from baseline to 2 weeks | 
| changes of The Disease Activity Score (DAS) 28 |  | from baseline to 1 month | 
| changes of The Disease Activity Score (DAS) 28 |  | from baseline to 6 months | 
| changes of The Disease Activity Score (DAS) 28 |  | from baseline to 12 months | 
| Rate of ACR(American College Of Rheumatology)50 |  | at 2 weeks | 
| Rate of ACR(American College Of Rheumatology)50 |  | at 1 month | 
| Rate of ACR(American College Of Rheumatology)50 |  | at 2 months | 
| Rate of ACR(American College Of Rheumatology)50 |  | at 6 months | 
| Rate of ACR(American College Of Rheumatology)50 |  | at 12 months | 
| change score of Health Assessment Questionnaire - Disability Index |  | from baseline to 2 weeks | 
| change score of Health Assessment Questionnaire - Disability Index |  | from baseline to 1 month | 
| change score of Health Assessment Questionnaire - Disability Index |  | from baseline to 2 months | 
| change score of Health Assessment Questionnaire - Disability Index |  | from baseline to 3 months | 
| change score of Health Assessment Questionnaire - Disability Index |  | from baseline to 6 months | 
| change score of Health Assessment Questionnaire - Disability Index |  | from baseline to 12 months | 
| change score of Patient Assessment of Arthritis Pain |  | from baseline to 2 weeks | 
| change score of Patient Assessment of Arthritis Pain |  | from baseline to 1 month | 
| change score of Patient Assessment of Arthritis Pain |  | from baseline to 2 months | 
| change score of Patient Assessment of Arthritis Pain |  | from baseline to 3 months | 
| change score of Patient Assessment of Arthritis Pain |  | from baseline to 6 months | 
| change score of Patient Assessment of Arthritis Pain |  | from baseline to 12 months | 
| change score of Patient Global Assessment of Arthritis |  | from baseline to 2 weeks | 
| change score of Patient Global Assessment of Arthritis |  | from baseline to 1 month | 
| change score of Patient Global Assessment of Arthritis |  | from baseline to 2 months | 
| change score of Patient Global Assessment of Arthritis |  | from baseline to 3 months | 
| change score of Patient Global Assessment of Arthritis |  | from baseline to 6 months | 
| change score of Patient Global Assessment of Arthritis |  | from baseline to 12 months | 
| change score of 36-item Short-Form Health Survey Questionnaire |  | form baseline to 2 weeks | 
| change score of 36-item Short-Form Health Survey Questionnaire |  | form baseline to 1 month | 
| change score of 36-item Short-Form Health Survey Questionnaire |  | form baseline to 2 months | 
| change score of 36-item Short-Form Health Survey Questionnaire |  | form baseline to 3 months | 
| change score of 36-item Short-Form Health Survey Questionnaire |  | form baseline to 6 months | 
| change score of 36-item Short-Form Health Survey Questionnaire |  | form baseline to 12 months | 
| change score of AIS Sleep Scale |  | from baseline to 2 weeks | 
| change score of AIS Sleep Scale |  | from baseline to 1 month | 
| change score of AIS Sleep Scale |  | from baseline to 2 months | 
| change score of AIS Sleep Scale |  | from baseline to 3 months | 
| change score of AIS Sleep Scale |  | from baseline to 6 months | 
| change score of AIS Sleep Scale |  | from baseline to 12 months | 
| rate of ACR20 |  | at 2 weeks | 
| rate of ACR20 |  | at 1 month | 
| rate of ACR20 |  | at 2 months | 
| rate of ACR20 |  | at 3 months | 
| rate of ACR20 |  | at 6 months | 
| rate of ACR20 |  | 12 months | 
| rate of ACR70 |  | at 2 weeks | 
| rate of ACR70 |  | at 1 month | 
| rate of ACR70 |  | at 2 months | 
| rate of ACR70 |  | at 3 months | 
| rate of ACR70 |  | at 6 months | 
| rate of ACR70 |  | at 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Juanbi Pill, Methotrexate, Active, Rheumatoid Arthritis