The purpose of this study is to determine whether Juanbi Pill combined with methotrexate are effective in the treatment of active Rheumatoid Arthritis (RA).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
4g, twice a day, 3month, oral
4g, twice a day, 3month, oral
5mg, once a week, 3 month, oral
Longhua Hospital, Shanghai University of TCM
Shanghai, Shanghai Municipality, China
RECRUITINGRate of ACR (American College Of Rheumatology) 50
Time frame: at 3 months
changes of The Disease Activity Score (DAS) 28
Time frame: from baseline to 3 months
changes of the van der Heijde modified Sharp score
Time frame: from baseline to 12 months
changes of The Disease Activity Score (DAS) 28
Time frame: from baseline to 2 weeks
changes of The Disease Activity Score (DAS) 28
Time frame: from baseline to 1 month
changes of The Disease Activity Score (DAS) 28
Time frame: from baseline to 6 months
changes of The Disease Activity Score (DAS) 28
Time frame: from baseline to 12 months
Rate of ACR(American College Of Rheumatology)50
Time frame: at 2 weeks
Rate of ACR(American College Of Rheumatology)50
Time frame: at 1 month
Rate of ACR(American College Of Rheumatology)50
Time frame: at 2 months
Rate of ACR(American College Of Rheumatology)50
Time frame: at 6 months
Rate of ACR(American College Of Rheumatology)50
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: at 12 months
change score of Health Assessment Questionnaire - Disability Index
Time frame: from baseline to 2 weeks
change score of Health Assessment Questionnaire - Disability Index
Time frame: from baseline to 1 month
change score of Health Assessment Questionnaire - Disability Index
Time frame: from baseline to 2 months
change score of Health Assessment Questionnaire - Disability Index
Time frame: from baseline to 3 months
change score of Health Assessment Questionnaire - Disability Index
Time frame: from baseline to 6 months
change score of Health Assessment Questionnaire - Disability Index
Time frame: from baseline to 12 months
change score of Patient Assessment of Arthritis Pain
Time frame: from baseline to 2 weeks
change score of Patient Assessment of Arthritis Pain
Time frame: from baseline to 1 month
change score of Patient Assessment of Arthritis Pain
Time frame: from baseline to 2 months
change score of Patient Assessment of Arthritis Pain
Time frame: from baseline to 3 months
change score of Patient Assessment of Arthritis Pain
Time frame: from baseline to 6 months
change score of Patient Assessment of Arthritis Pain
Time frame: from baseline to 12 months
change score of Patient Global Assessment of Arthritis
Time frame: from baseline to 2 weeks
change score of Patient Global Assessment of Arthritis
Time frame: from baseline to 1 month
change score of Patient Global Assessment of Arthritis
Time frame: from baseline to 2 months
change score of Patient Global Assessment of Arthritis
Time frame: from baseline to 3 months
change score of Patient Global Assessment of Arthritis
Time frame: from baseline to 6 months
change score of Patient Global Assessment of Arthritis
Time frame: from baseline to 12 months
change score of 36-item Short-Form Health Survey Questionnaire
Time frame: form baseline to 2 weeks
change score of 36-item Short-Form Health Survey Questionnaire
Time frame: form baseline to 1 month
change score of 36-item Short-Form Health Survey Questionnaire
Time frame: form baseline to 2 months
change score of 36-item Short-Form Health Survey Questionnaire
Time frame: form baseline to 3 months
change score of 36-item Short-Form Health Survey Questionnaire
Time frame: form baseline to 6 months
change score of 36-item Short-Form Health Survey Questionnaire
Time frame: form baseline to 12 months
change score of AIS Sleep Scale
Time frame: from baseline to 2 weeks
change score of AIS Sleep Scale
Time frame: from baseline to 1 month
change score of AIS Sleep Scale
Time frame: from baseline to 2 months
change score of AIS Sleep Scale
Time frame: from baseline to 3 months
change score of AIS Sleep Scale
Time frame: from baseline to 6 months
change score of AIS Sleep Scale
Time frame: from baseline to 12 months
rate of ACR20
Time frame: at 2 weeks
rate of ACR20
Time frame: at 1 month
rate of ACR20
Time frame: at 2 months
rate of ACR20
Time frame: at 3 months
rate of ACR20
Time frame: at 6 months
rate of ACR20
Time frame: 12 months
rate of ACR70
Time frame: at 2 weeks
rate of ACR70
Time frame: at 1 month
rate of ACR70
Time frame: at 2 months
rate of ACR70
Time frame: at 3 months
rate of ACR70
Time frame: at 6 months
rate of ACR70
Time frame: at 12 months