The Efficacy and Safety of Fang yi Qing Feng Shi Granules in Subjects With Rheumatoid Arthritis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase 2 Randomised, Double-blind, Placebo-controlled Multiple Ascending Dose Study Evaluate the Efficacy and Safety of Fang yi Qing Feng Shi Granules in Subjects With Rheumatoid Arthritis

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Fang yi qing feng shi granule
* Drug: placebo
* Drug: Methotrexate
* Drug: Acetaminophen tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects have the diagnosis of Rheumatoid Arthritis in active state. Subjects have the Traditional Chinese Medicine (TCM) diagnosis ofArthralgic Syndrome with the sign of dampness obstructing connecting vessel。 Subjects must stop the medicine at least three month，which is Diseases modifying anti-rheumatic drugs(including glucocorticoids). Male or female subjects, between the ages of 18 and 65 years old. Joint function grading and ray classification are both in Ⅰ～Ⅲ. Subjects agree to participate in this study and sign the informed consent form. Exclusion Criteria: Subjects with systemic lupus erythematosus,sicca syndrome, or severe osteoarthropathy will be excluded. Subjects with severe rheumatic arthritis are loss of ability Allergic to test drugs(basic treatment or drug combination),Allergic constitution(Allergic to two or more drugs). Female subject who was pregnant or breast-feeding or considering becoming pregnant. Subjects with sever diseases in Cardiovascular, brain, lung, liver, kidney and hematopoietic system. The Liver function (ALT,AST) and kidney function（BUN,Cr）is higher than normal. The Blood Routine (leukocyte count,platelet count)is lower than normal. Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High dose group<br>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. | Drug: Fang yi qing feng shi granule<br>* 10g, Oral,Three each time, 3 times a day,for 3 months;<br>Drug: Methotrexate<br>* 7.5-15mg per week，All patients should be used<br>Drug: Acetaminophen tablets<br>* Oral,0.5g, 1 2 times a day, when vas=10<br>|
| Experimental: Low dose group<br>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. | Drug: Fang yi qing feng shi granule<br>* 10g, Oral,Three each time, 3 times a day,for 3 months;<br>Drug: placebo<br>* 10g, Oral,Three each time, 3 times a day,for 3 months<br>Drug: Methotrexate<br>* 7.5-15mg per week，All patients should be used<br>Drug: Acetaminophen tablets<br>* Oral,0.5g, 1 2 times a day, when vas=10<br>|
| Placebo Comparator: The placebo group<br>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. | Drug: placebo<br>* 10g, Oral,Three each time, 3 times a day,for 3 months<br>Drug: Methotrexate<br>* 7.5-15mg per week，All patients should be used<br>Drug: Acetaminophen tablets<br>* Oral,0.5g, 1 2 times a day, when vas=10<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 |