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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Fang yi qing feng shi granule
placebo
Methotrexate
Acetaminophen tablets
Sponsored by
Maoxiang Group Jilin Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hubei provincial hospital of tcm
  • Hospital of Liaoning University of Traditional Chinese Medicine
  • LONGHUA Hospital Shanghai University of TCM
  • First Teaching hospital of Tianjin University of Traditional Chinese Medicine
  • Second affiliated hospital of Tianjin university of tcm

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

High dose group

Low dose group

The placebo group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

The percentage of Therapeutic effect with American College of Rheumatology standards (ACR)

Secondary Outcome Measures

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"
Safety assessments will be based on adverse event reports and the results of vital sign measurements, electrocardiogram, physical examinations, and clinical laboratory tests
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).
The change of laboratory test indexes (ESR、RF、CRP)
Traditional Chinese Medicine(TCM) characteristics evaluative index: Traditional Chinese medicine Syndrome Scale
The score of clinical symptoms and symptom integral
Change in the days and doses using of analgesic(Paracetamol Tablets)

Full Information

First Posted
December 26, 2013
Last Updated
October 7, 2015
Sponsor
Maoxiang Group Jilin Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02029599
Brief Title
The Efficacy and Safety of Fang yi Qing Feng Shi Granules in Subjects With Rheumatoid Arthritis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maoxiang Group Jilin Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High dose group
Arm Type
Experimental
Arm Description
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.
Arm Title
Low dose group
Arm Type
Experimental
Arm Description
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.
Arm Title
The placebo group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Fang yi qing feng shi granule
Intervention Description
10g, Oral,Three each time, 3 times a day,for 3 months;
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
10g, Oral,Three each time, 3 times a day,for 3 months
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
7.5-15mg per week，All patients should be used
Intervention Type
Drug
Intervention Name(s)
Acetaminophen tablets
Intervention Description
Oral,0.5g, 1~2 times a day, when vas=10
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
The change of Rheumatoid Arthritis (RA) associated symptoms and signs
Description
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
Title
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
Title
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
Title
The change of laboratory test indexes (ESR、RF、CRP)
Time Frame
baseline,week12
Title
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
Title
The score of clinical symptoms and symptom integral
Time Frame
Taken at day 1 (baseline) and Change from Baseline in 4th,8th,12th week
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
wei liu
Organizational Affiliation
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hubei provincial hospital of tcm
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Hospital of Liaoning University of Traditional Chinese Medicine
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
LONGHUA Hospital Shanghai University of TCM
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
First Teaching hospital of Tianjin University of Traditional Chinese Medicine
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
Second affiliated hospital of Tianjin university of tcm
City
Tianjin
State/Province
Tianjin
Country
China

12. IPD Sharing Statement

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

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