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The aim of this study is to assess the efficacy and safety of Luo-Fu-Shan Plaster in patients with Rheumatoid Arthritis.
The investigators are inspired by Chinese traditonal herb, an therapy for thousands of years, and take its advantage to make Luo-Fu-Shan Plaster in order to get an effective and safe treatment for active RA patients. The study is a multicenter, randomized, double-blind, placebo-controlled trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Luo-Fu-Shan Plaster 10g | Experimental | 10g,once daily,4 weeks |
|
| Placebo | Placebo Comparator | 10g,once daily,4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Luo-Fu-Shan Plaster | Drug | Luo-Fu-Shan Plaster 10g,once daily,4 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The changes of Visual Analogue Scale(VAS) pain score | The changes of Visual Analogue Scale(VAS) pain score of global health status, the patient's assessment of pain on a visual analogue scale. The score their pain intensity in the most affected joint on a 0-10 cm Visual Analogue Scale Score (VAS), ranging from no pain (0) to extremely pain (10). | Day 1 to Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| The changes of the Disease Activiyu Score (DAS28) | The changes of the Disease Activity Score (DAS28).The score their pain intensity in the most affected joint on a 0-10 cm Disease Activity Score (DAS28), ranging from no pain (0) to extremely pain (10). | Day 1 to Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| The score of the Health Assessment Questionnaire (HAQ-DI) | the patient's assessment of function using a modified version of the Health Assessment Questionnaire (HAQ).The score their level, ranging from no difficuties(0),some difficulties(1),a lot of difficuties(2) to coud not finish(3). | Day1 to Week 4 |
| The score of the RA-PRO |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiang Quan, PhD | Contact | 86-010-88001132 | doctorjq@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Jiang Quan, PhD | Guang'anmen Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guang'anmen Hospital of China Academy of Chinese Medical Sciences | Beijing | Beijing Municipality | China |
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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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180 subjects will be randomized to two parallel groups (90 subjects per group) to receive Luo-Fu-Shan Plaster 10g once daily. Placebo will be administered to individuals randomized to that treatment group in a form identical to the Luo-Fu-Shan Plaster. The first investigational medicinal product dose will be administered the day after the randomization.
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| The placebo 10g |
| Drug |
Placebo 10g,once daily,4 weeks |
|
|
the patient's assessment of function using a modified version of the RA-PRO which ranging from 0 to 3. |
| Day 1 to Week 4 |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |