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Rheumatoid Arthritis (RA) is an autoimmune disease that results in a chronic inflammatory disorder that may affect many synovial joints, and may cause serious disability. It has been confirmed that Tripterygium wilfordii Hook F has effects of anti-inflammatory, immunosuppressive and cartilage protection. This is a prospective randomized controlled study to evaluated the efficacy and safety of external application with compound Tripterygium wilfordii Hook F in treating of patients with rheumatoid arthritis (RA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical Tripterygium group | Experimental | Patients were treated with topical compound tripterygium for 1 hour, twice per day. Area dosages were as followed that each 1st to 5th metacarpophalangeal joints (MCPJs), 1st to 5th proximal interphalangeal joints (PIPJs) and wrist was 3 ml, each elbow and ankle was 5 ml, each knee was 10 ml. |
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| Topical Placebo group | Placebo Comparator | Patients were treated with topical placebo for 1 hour, twice per day. The dosage was the same as the topical tripterygium group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical compound tripterygium | Drug | Topical compound tripterygium was applied for the pain and swollen joints on non-woven fabric for 1 hour, twice per day. |
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| Measure | Description | Time Frame |
|---|---|---|
| ACR20 criteria | To meet the 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 ESR or serum C-reactive protein (CRP) level. | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| ACR50 criteria | To meet the 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 Health Assessment Questionnaire (HAQ), and the ESR or serum C-reactive protein (CRP) level. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Quan Jiang | Guang'anmen Hospital | Principal Investigator |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 27, 2017 | |
| Unrelease | Yes | |
| Release | Jul 20, 2017 | |
| Reset | Aug 17, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 27, 2017 | Yes | |||
| Jul 20, 2017 |
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| Placebo | Drug | The topical placebo recipe composes viscous agent which matches by the sucrose, and the usage and dosage were the same as the topical compound tripterygium group. |
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| Week 4 |
| 28-joint count Disease Activity Score (DAS28) | Baselin and week 4 |
| Aug 17, 2017 |