Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Shanghai Yueyang Integrated Medicine Hospital | OTHER |
| Longhua Hospital | OTHER |
| Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Juanbi group | Experimental | participants should administrate both Juanbi pill and Methotrexate |
|
| placebo group | Placebo Comparator | participants should administrate both Juanbi pill placebo and Methotrexate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Juanbi pill | Drug | 4g, twice a day, 3month, oral |
|
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongjun Wang, Doctor | Contact | 86-189177763018 | yjwang8888@126.com | |
| Qianqian Liang, Doctor | Contact | 86-021-64875390 |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Longhua Hospital, Shanghai University of TCM | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39707138 | Derived | Jia QY, Wang YR, Sun DW, Mao JC, Xue L, Gu XH, Yu X, Piao XM, Xu H, Liang QQ. Efficacy and Safety of Juan Bi Pill with Add-on Methotrexate in Active Rheumatoid Arthritis: A 48-Week, Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial. Chin J Integr Med. 2025 Feb;31(2):99-107. doi: 10.1007/s11655-024-3768-7. Epub 2024 Dec 21. | |
| 29558967 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Juanbi pill placebo | Drug | 4g, twice a day, 3month, oral |
|
|
| Methotrexate | Drug | 5mg, once a week, 3 month, oral |
|
|
| 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 |
| Wang Q, Wang YR, Jia QY, Liu L, Xu CQ, Wang XY, Yao M, Cui XJ, Shi Q, Wang YJ, Liang QQ. The efficacy of the traditional Chinese medicine Juanbi pill combined with methotrexate in active rheumatoid arthritis: study protocol for a randomized controlled trial. Trials. 2018 Mar 20;19(1):188. doi: 10.1186/s13063-018-2555-1. |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001519 | Behavior |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |