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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
240
10g, Oral,Three each time, 3 times a day,for 3 months;
10g, Oral,Three each time, 3 times a day,for 3 months
7.5-15mg per week,All patients should be used
Hubei provincial hospital of tcm
Wuhan, Hubei, China
Hospital of Liaoning University of Traditional Chinese Medicine
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
The percentage of Therapeutic effect with American College of Rheumatology standards (ACR)
Time frame: Taken at day 1 (baseline) and Change from Baseline in 4th,8th,12th week
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"
Time frame: 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
Time frame: 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).
Time frame: Taken at day 1 (baseline) and Change from Baseline in 4th,8th,12th week
The change of laboratory test indexes (ESR、RF、CRP)
Time frame: baseline,week12
Traditional Chinese Medicine(TCM) characteristics evaluative index: Traditional Chinese medicine Syndrome Scale
Time frame: Taken at day 1 (baseline) and Change from Baseline in 4th,8th,12th week
The score of clinical symptoms and symptom integral
Time frame: 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)
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Oral,0.5g, 1\~2 times a day, when vas=10
Second affiliated hospital of Tianjin university of tcm
Tianjin, Tianjin Municipality, China
Time frame: Taken at day 1 (baseline) and Change from Baseline in 4th,8th,12th week