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| Name | Class |
|---|---|
| Peking Union Medical College Hospital | OTHER |
| The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine | OTHER |
| The 980th Hospital of PLA Joint Logistics Support Force | UNKNOWN |
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The group used a randomized controlled trial to conduct a post-marketing re-evaluation study of Wangbi granules. The study was conducted to observe the degree of clinical remission in rheumatoid arthritis patients with low disease activity after standard methotrexate and tofacitinib citrate treatment, using a combination of Chinese and Western medicine treatment with Wangbi granules. The study aims to provide evidence-based medical evidence to improve the clinical efficacy of rheumatoid arthritis, enhance the depth of remission, and improve the diagnosis and treatment of rheumatoid arthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Experimental | Methotrexate 7.5-15mg qw plus tofacitab 5mg bid, combined with Wangbi granules 12.0g tid, treatment course 3 months. |
|
| control group | Active Comparator | Methotrexate 7.5-15mg qw plus tofacitab 5mg bid, combined with Wangbi granules simulant 12.0g tid, treatment course 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wangbi granules | Drug | Methotrexate 7.5-15mg qw plus tofacitab 5mg bid, combined with Wangbi granules 12.0g tid, treatment course 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| DAS28 | Disease mobility score for 28 joints, higher scores indicate higher disease activity | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue Scale-14 | assessing the patient's fatigue level, the higher the score, the more severe the fatigue | 12 weeks |
| visual analogue scale | Patients score according to the level of pain they feel, there are 10 scales from 0-10, with 0 representing no pain and 10 representing severe pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zihan Wang, Dr | Contact | +8618810902100 | wzhbucm@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Recruiting | Beijing | 100029 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36855169 | Derived | Wang J, Wang Z, Lan T, Zhang L, Li Z, Wang X, Zou Q, Wang Y, Li Y, Luo R, Zhang N, Xu Y, Li M, Tao Q. Wangbi granule as a combination therapy to achieve clinical deep remission in rheumatoid arthritis: protocol for a multicenter, triple-blind, randomised, placebo-controlled trial. Chin Med. 2023 Feb 28;18(1):22. doi: 10.1186/s13020-023-00728-6. |
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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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| The Second Affiliated Hospital of Zhejiang Chinese Medical University | OTHER |
| Southwest Hospital, China | OTHER |
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| Wangbi granules simulant | Drug | Methotrexate 7.5-15mg qw plus tofacitab 5mg bid, combined with Wangbi granules simulant 12.0g tid, treatment course 3 months. |
|
| 12 weeks |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |