The Efficacy of the Traditional Chinese Medicine Niubang Pill Combined With Methotrexate on Active Rheumatoid Arthritis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Efficacy of the Traditional Chinese Medicine Niubang Pill Combined With Methotrexate on Active Rheumatoid Arthritis: a Study Protocol for a Multicenter, Randomized, Controlled Clinical Trial

Conditions
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Niu Bang Zi Pill, Rheumatoid Arthritis

Intervention / Treatment
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* Drug: NiuBangZi pill or NiuBangZi pill placebo


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: NiuBangZi pill group<br>Drug: NiuBangZi pill (4g, twice a day, 3 months, oral) Drug: methotrexate (5mg, once a week, 3 months, oral) participants should administrate both NiuBangZi pill and methotrexate | Drug: NiuBangZi pill or NiuBangZi pill placebo<br>* 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.<br>|
| Placebo Comparator: Placeo group<br>Drug: NiuBangZi placebo pill (4g, twice a day, 3 months, oral) Drug: methotrexate (5mg, once a week, 3 months, oral) participants should administrate both NiuBangZi placebo pill and methotrexate | Drug: NiuBangZi pill or NiuBangZi pill placebo<br>* 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.<br>|

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 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of ACR70 |  | at 2 months | 
| rate of ACR70 |  | at 3 months | 
| rate of ACR70 |  | at 6 months | 
| rate of ACR70 |  | at 12 months | 
| 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 |  | from baseline to 2 weeks | 
| change score of 36-item Short-Form Health Survey Questionnaire |  | from baseline to 1 month | 
| change score of 36-item Short-Form Health Survey Questionnaire |  | from baseline to 2 months | 
| change score of 36-item Short-Form Health Survey Questionnaire |  | from baseline to 3 months | 
| change score of 36-item Short-Form Health Survey Questionnaire |  | from baseline to 6 months | 
| change score of 36-item Short-Form Health Survey Questionnaire |  | from baseline to 12 months | 
| change score of MOS Sleep Scale |  | from baseline to 2 weeks | 
| change score of MOS Sleep Scale |  | from baseline to 1 month | 
| change score of MOS Sleep Scale |  | from baseline to 2 months | 
| change score of MOS Sleep Scale |  | from baseline to 3 months | 
| change score of MOS Sleep Scale |  | from baseline to 6 months | 
| change score of MOS 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 |  | at 12 months | 
| rate of ACR70 |  | at 2 weeks | 
| rate of ACR70 |  | at 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Traditional Chinese medicine, Niu Bang Zi pill, methotrexate, active rheumatoid arthritis