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Tripterygium wilfordii Hook F (TwHF), a traditional Chinese herb, is widely used in China for treating Rheumatoid Arthritis (RA), but limited only for elderly RA patients because of its reproductive system toxicity. The investigators are inspired by Chinese external therapy, an immemorial therapy for thousands of years, and take its advantage to make TwHF topically in order to get an effective and safe treatment for active RA patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| topical TwHF gel group | Experimental | Topical TwHF gel recipe composes Tripterygium wilfordii Hook F, Mangxiao (Mirabilite), Chuanxiong (Rhizoma Ligustici), Ruxiang (Olibanum), Moyao (M yrrh) (prescription proportion is 4:4:2:2:1).Each gel is 20 gram(g). TwHF gel is applied for 1st to 5th metacarpophalangeal joints, 1st to 5th proximal interphalangeal joints, wrists, knees and ankles 20g for 1 hour, once per day from week 0 through week 4 and 10g for 1 hour, once per day from week 5 through week 8. |
|
| placebo group | Placebo Comparator | Placebo recipe composes viscous agent which matches by the sucrose. The usage and dosage of topical TwHF and placebo are the same. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical tripterygium gel | Drug |
| ||
| Placebo gel |
| Measure | Description | Time Frame |
|---|---|---|
| Twenty percent improvement in the American College of Rheumatology criteria | a patient must have 20% or greater improvement in both tender and swollen joints (28 tender and 28 swollen joints were assessed) and 20% or greater improvement in 3 or more of the following: the physician's or patient's assessment of global health status, the patient's assessment of pain on a visual analogue scale, the patient's assessment of function using a modified version of the Health Assessment Questionnaire (HAQ), and the erythrocyte sedimentation rate (ESR) or serum C-reactive protein (CRP) level. | Week 8. |
| Twenty percent improvement in the American College of Rheumatology criteria | Week 4. |
| Measure | Description | Time Frame |
|---|---|---|
| Fifty percent improvement in the American College of Rheumatology criteria | a patient must have 50% or greater improvement in both tender and swollen joints (28 tender and 28 swollen joints were assessed) and 50% or greater improvement in 3 or more of the following: the physician's or patient's assessment of global health status, the patient's assessment of pain on a visual analogue scale, the patient's assessment of function using a modified version of the HAQ), and the ESR or CRP level. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Quan Jiang, MD. PhD. | Rheumatology Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guang'anmen Hospital | Beijing | Beijing Municipality | 100053 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28870177 | Derived | Jiang Q, Tang XP, Chen XC, Xiao H, Liu P, Jiao J. Will Chinese external therapy with compound Tripterygium wilfordii hook F gel safely control disease activity in patients with rheumatoid arthritis: design of a double-blinded randomized controlled trial. BMC Complement Altern Med. 2017 Sep 5;17(1):444. doi: 10.1186/s12906-017-1957-z. |
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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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|
| Week 4 and week 8. |
| The changes of the 28-joint count Disease Activity Score (DAS28) | Week 4 and week 8. |
| The changes of Visual Analogue Scale (VAS) pain score | Week 1, 2, 3, 4, 5, 6, 7, and 8. |
| The change of knee synovitis classification as assessed by musculoskeletal ultrasound (MSUS) | Synovitis classification is specific as follows: 0 level, no doppler signal; level 1: three independent point or 2 successive or 1 and 2 in independent dot doppler signal; level 2: doppler signal < 50% of the synovial membrane area; level 3 doppler signal is the synovium in > 50% of the area. | Week 2, 4, and 8. |
| The change of knee synovial hyperplasia classification as assessed by MSUS | Synovial hyperplasia classification is specific as follows: 0 level, no synovial hyperplasia; level 1: synovial hyperplasia of mild, not more than bone surface high attachment; level 2: synovial hyperplasia more than bone surface high wire, but not more than the backbone; level 3: synovial hyperplasia more than bone surface peak wires, and extends along the backbone of the side. | Week 2, 4, and 8. |
| The change of knee articular cavity effusion as assessed by MSUS | Articular cavity effusion adopts binary evaluation, namely: 0: normal, 1: abnormal. | Week 2, 4, and 8. |
| The change of knee bone erosion classification as assessed by MSUS | Bone erosion classification adopts binary evaluation, namely: 0: normal, 1: abnormal. | Week 2, 4, and 8. |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |