Rheumatoid arthritis (RA) is a chronic, systemic, inflammatory autoimmune disease that results in the destruction of joints, connective tissues, muscle, tendons and fibrous tissue. Effective therapy to manage RA still does not exit at present. Jia Wei Niu Bang Zi pill (NBZP) consists of Chinese herbals which has been widely used in the treatment of RA patients in China for hundreds of years to relieve pain and prevent the affected joints pejorative. However, there is no systematic trials to prove the effect of NBZP for management of RA.
A multicenter, randomized, double-blind, placebo-controlled clinical trials will be conducted to determine whether the NBZP could make an effect of pain relief and joints protection. 120 patients suffering from active RA will be enrolled and treated with NBZP or placebo for 3 months. The primary outcome measures are the rate of American College of Rheumatology (ACR) 50, changes of the Disease Activity Score (DAS) 28 from the baseline to 3 months and the van der Heijde modified Sharp score would be measured from the baseline to 12 months. The second outcome measures are the change rate of ACR20, ACR70, Health Assessment Questionnaire - Disability Index, change score of Patient Assessment of Arthritis Pain, Patient Global Assessment of Arthritis, Patient Global Assessment of Arthritis and the Athens Insomnia Scale (AIS) from the baseline to 2 weeks, 1 month, 2 months, 3 months, 6 months, and 12 months' follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
For the treatment group (NiuBangZi pill group), patients will be instructed to dissolve NiuBangZi pill (4 g) in 200 mL hot water and take the solution orally twice a day for 3 months. While patients in the placebo group will take NiuBangZi pill placebo as the same way. Besides that, both groups will also administrate MTX (5 mg per week) in addition, and glucocorticoid (less than 5mg a day) if necessary, but any other drugs especially herbs not permit.
Longhua Hospital
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 3 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
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: from baseline to 2 weeks
change score of 36-item Short-Form Health Survey Questionnaire
Time frame: from baseline to 1 month
change score of 36-item Short-Form Health Survey Questionnaire
Time frame: from baseline to 2 months
change score of 36-item Short-Form Health Survey Questionnaire
Time frame: from baseline to 3 months
change score of 36-item Short-Form Health Survey Questionnaire
Time frame: from baseline to 6 months
change score of 36-item Short-Form Health Survey Questionnaire
Time frame: from baseline to 12 months
change score of MOS Sleep Scale
Time frame: from baseline to 2 weeks
change score of MOS Sleep Scale
Time frame: from baseline to 1 month
change score of MOS Sleep Scale
Time frame: from baseline to 2 months
change score of MOS Sleep Scale
Time frame: from baseline to 3 months
change score of MOS Sleep Scale
Time frame: from baseline to 6 months
change score of MOS 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: at 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
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