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

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

The aim of this study is to evaluate the efficacy and safety of Fang yi qing Feng shi granules in subjects with Rheumatoid Arthritis.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Hubei
      • Wuhan, Hubei, China
        • Hubei Provincial Hospital of TCM
    • Liaoning
      • Shenyang, Liaoning, China
        • Hospital of Liaoning University of Traditional Chinese Medicine
    • Shanghai
      • Shanghai, Shanghai, China
        • LONGHUA Hospital Shanghai University of TCM
    • Tianjin
      • Tianjin, Tianjin, China
        • First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
      • Tianjin, Tianjin, China
        • Second affiliated hospital of Tianjin university of tcm

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High dose group
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.
10g, Oral,Three each time, 3 times a day,for 3 months;
7.5-15mg per week,All patients should be used
Oral,0.5g, 1~2 times a day, when vas=10
Experimental: Low dose group

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.

10g, Oral,Three each time, 3 times a day,for 3 months;
7.5-15mg per week,All patients should be used
Oral,0.5g, 1~2 times a day, when vas=10
10g, Oral,Three each time, 3 times a day,for 3 months
Placebo Comparator: The placebo group
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.
7.5-15mg per week,All patients should be used
Oral,0.5g, 1~2 times a day, when vas=10
10g, Oral,Three each time, 3 times a day,for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
Time Frame: 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"
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
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
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
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
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
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)
Time Frame: Taken at day 1 (baseline) and Change from Baseline in 4th,8th,12th week
Taken at day 1 (baseline) and Change from Baseline in 4th,8th,12th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: wei liu, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

December 26, 2013

First Submitted That Met QC Criteria

January 6, 2014

First Posted (Estimate)

January 8, 2014

Study Record Updates

Last Update Posted (Estimate)

October 9, 2015

Last Update Submitted That Met QC Criteria

October 7, 2015

Last Verified

October 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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