Arthritis, Rheumatoid
Conditions
Keywords
Rheumatoid Arthritis, External therapy, Herb medicine
Brief summary
The aim of this study is to assess the efficacy and safety of Luo-Fu-Shan Plaster in patients with Rheumatoid Arthritis.
Detailed description
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.
Interventions
DRUGLuo-Fu-Shan Plaster
Luo-Fu-Shan Plaster 10g，once daily，4 weeks
DRUGThe placebo 10g
Placebo 10g，once daily，4 weeks
Sponsors
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or female subjects aged 18 to 75 years (time of get informed consent) * Documented diagnosis of rheumatoid arthritis, as defined by the American Rheumatism Association 1987 Revised Criteria. * Documented diagnosis of damp-heat syndrome according to Traditional Chinese Medicine. * If patients are receiving Disease-modifying anti-rheumatic drugs (DMARDs), then the doses should have been kept stable for at least 12 weeks. * If patients are receiving non-steroidal anti-inflammatory drugs (NSAIDs) or orally Chinese herbal medicine, then the doses should have been kept stable for at least 4 weeks.
Exclusion criteria
* Skin allergies or broken skin; * Taking glucocorticoids,more than 10 mg daily. * Female patients who are pregnant, breast-feeding or planed to be pregnant;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The changes of Visual Analogue Scale(VAS) pain score | Day 1 to Week 4 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The changes of the Disease Activiyu Score (DAS28) | Day 1 to Week 4 | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| The score of the Health Assessment Questionnaire (HAQ-DI) | Day1 to Week 4 | 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). |
| The score of the RA-PRO | Day 1 to Week 4 | the patient's assessment of function using a modified version of the RA-PRO which ranging from 0 to 3. |
Countries
China
Contacts
Primary ContactJiang Quan, PhD
Outcome results
None listed