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| Name | Class |
|---|---|
| Shanghai Yueyang Integrated Medicine Hospital | OTHER |
| Longhua Hospital | OTHER |
| Shanghai 7th People's Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NiuBangZi pill group | Experimental | 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 |
|
| Placeo group | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NiuBangZi pill or NiuBangZi pill placebo | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongjun Wang, Doctor | Contact | 86-18917763018 | yjwang8888@126.com | |
| Qianqian Liang, Doctor | Contact | 86-021-64875390 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Longhua Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30732199 | Derived | Wang YR, Liu L, Wang XY, Wang Q, Yao M, Cui XJ, Mao JC, Liu J, Gu XH, Chen YL, Yu X, Shi Q, Liang QQ, Wang YJ. The efficacy of the traditional Chinese medicine Jia Wei Niu Bang Zi granule combined with methotrexate in treating active rheumatoid arthritis: A multicenter, randomized, double-blinded controlled clinical trial. Medicine (Baltimore). 2019 Feb;98(6):e14424. doi: 10.1097/MD.0000000000014424. |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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|
| 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 |
| rate of ACR70 | at 2 months |
| rate of ACR70 | at 3 months |
| rate of ACR70 | at 6 months |
| rate of ACR70 | at 12 months |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |