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

Phase 2

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Fang yi qing feng shi granule; Drug: placebo; Drug: Methotrexate; Drug: Acetaminophen tablets

• Registration Number: NCT02029599
• Lead Sponsor: Maoxiang Group Jilin Pharmaceutical Co., Ltd.

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-12-26
• Study First Submitted QC: 2014-01-06
• Study First Posted: 2014-01-08
• Study Start: 2014-03
• Primary Completion: 2015-08
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-07
• Last Update Posted: 2015-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1. Subjects have the diagnosis of Rheumatoid Arthritis in active state.
2. Subjects have the Traditional Chinese Medicine (TCM) diagnosis ofArthralgic Syndrome with the sign of dampness obstructing connecting vessel。
3. Subjects must stop the medicine at least three month，which is Diseases modifying anti-rheumatic drugs(including glucocorticoids).
4. Male or female subjects, between the ages of 18 and 65 years old.
5. Joint function grading and ray classification are both in Ⅰ～Ⅲ.
6. Subjects agree to participate in this study and sign the informed consent form.

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Exclusion Criteria

1. Subjects with systemic lupus erythematosus,sicca syndrome, or severe osteoarthropathy will be excluded.
2. Subjects with severe rheumatic arthritis are loss of ability
3. Allergic to test drugs(basic treatment or drug combination),Allergic constitution(Allergic to two or more drugs).
4. Female subject who was pregnant or breast-feeding or considering becoming pregnant.
5. Subjects with sever diseases in Cardiovascular, brain, lung, liver, kidney and hematopoietic system.
6. The Liver function (ALT,AST) and kidney function（BUN,Cr）is higher than normal.
7. The Blood Routine (leukocyte count,platelet count)is lower than normal.
8. Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High dose group	Fang yi qing feng shi granule	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.
High dose group	Acetaminophen tablets	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	Fang yi qing feng shi granule	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.
Low dose group	placebo	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.
Low dose group	Acetaminophen tablets	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	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.
The placebo group	Acetaminophen tablets	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.
High dose group	Methotrexate	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	Methotrexate	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	Methotrexate	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
The change of Rheumatoid Arthritis (RA) associated symptoms and signs	Taken at day 1 (baseline) and Change from Baseline in 4th,8th,12th week	The symptoms and signs include "Tender joint count,swollen joint count,time of morning stiffness,mean grip strength, VAS score,Jint function"
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
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
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

Trial Locations

Locations (5)

Hubei provincial hospital of tcm; 🇨🇳 Wuhan, Hubei, China

Hospital of Liaoning University of Traditional Chinese Medicine; 🇨🇳 Shenyang, Liaoning, China

First Teaching hospital of Tianjin University of Traditional Chinese Medicine; 🇨🇳 Tianjin, Tianjin, China

Second affiliated hospital of Tianjin university of tcm; 🇨🇳 Tianjin, Tianjin, China

LONGHUA Hospital Shanghai University of TCM; 🇨🇳 Shanghai, Shanghai, China