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The aim of this study is to evaluate the efficacy and safety of Fang yi qing Feng shi granules in subjects with Rheumatoid Arthritis.
Fang yi qing feng shi granules is the chinese patent medicine, which contains 8 kinds of chinese medicine .
Fang yi qing feng shi granules was approved by China Food and Drug Administration (CFDA) in 2005, produced by means of modern technology by Maoxiang Group Jilin Pharmaceutical Co., Ltd.The study is a multi-center, double -blind, placebo -controlled, randomized in Chinese subjects with Rheumatoid Arthritis to assess treatment effect and safety in the subjects treated with Fang yi qing feng shi granules versus subjects treated with placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose group | Experimental | Fang yi qing feng shi granule, Oral,10g, 3 times a day, Oral,for 3 months Methotrexate,Oral,7.5-15mg per week Acetaminophen tablets,Oral,0.5g, 1~2 times a day, when vas=10. |
|
| Low dose group | Experimental | Fang yi qing feng shi granule,Oral,10g, 2 time a day, taking morning and evening,for 3 months. placebo,Oral,10g, 1 time a day, taking noon ,for 3 months. Methotrexate,Oral,7.5-15mg per week. Acetaminophen tablets,Oral,0.5g, 1~2 times a day, when vas=10. |
|
| The placebo group | Placebo Comparator | placebo,Oral,10g, 3 time a day ,for 3 months. Methotrexate,Oral,7.5-15mg per week. Acetaminophen tablets,Oral,0.5g, 1~2 times a day, when vas=10. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fang yi qing feng shi granule | Drug | 10g, Oral,Three each time, 3 times a day,for 3 months; |
|
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of Therapeutic effect with American College of Rheumatology standards (ACR) | Taken at day 1 (baseline) and Change from Baseline in 4th,8th,12th week |
| Measure | Description | Time Frame |
|---|---|---|
| The change of Rheumatoid Arthritis (RA) associated symptoms and signs | The symptoms and signs include "Tender joint count,swollen joint count,time of morning stiffness,mean grip strength, VAS score,Jint function" | Taken at day 1 (baseline) and Change from Baseline in 4th,8th,12th week |
| Safety assessments will be based on adverse event reports and the results of vital sign measurements, electrocardiogram, physical examinations, and clinical laboratory tests |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| wei liu | First Teaching Hospital of Tianjin University of Traditional Chinese Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hubei provincial hospital of tcm | Wuhan | Hubei | China | |||
| Hospital of Liaoning University of Traditional Chinese Medicine |
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| placebo | Drug | 10g, Oral,Three each time, 3 times a day,for 3 months |
|
| Methotrexate | Drug | 7.5-15mg per week,All patients should be used |
|
| Acetaminophen tablets | Drug | Oral,0.5g, 1~2 times a day, when vas=10 |
|
| Taken at day 1 (baseline) and Change from Baseline in 4th,8th,12th week |
| The subjects of their comprehensive evaluation of disease activity(AIMS),The observer to the comprehensive evaluation of disease activity in the study(AIMS),The subjects of physical function evaluation(HAQ). | Taken at day 1 (baseline) and Change from Baseline in 4th,8th,12th week |
| The change of laboratory test indexes (ESR、RF、CRP) | baseline,week12 |
| Traditional Chinese Medicine(TCM) characteristics evaluative index: Traditional Chinese medicine Syndrome Scale | Taken at day 1 (baseline) and Change from Baseline in 4th,8th,12th week |
| The score of clinical symptoms and symptom integral | Taken at day 1 (baseline) and Change from Baseline in 4th,8th,12th week |
| Change in the days and doses using of analgesic(Paracetamol Tablets) | Taken at day 1 (baseline) and Change from Baseline in 4th,8th,12th week |
| Shenyang |
| Liaoning |
| China |
| LONGHUA Hospital Shanghai University of TCM | Shanghai | Shanghai Municipality | China |
| First Teaching hospital of Tianjin University of Traditional Chinese Medicine | Tianjin | Tianjin Municipality | China |
| Second affiliated hospital of Tianjin university of tcm | Tianjin | Tianjin Municipality | China |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D008727 | Methotrexate |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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