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
1 other identifier
interventional
240
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 rheumatoid-arthritis
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 26, 2013
CompletedFirst Posted
Study publicly available on registry
January 8, 2014
CompletedStudy Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedOctober 9, 2015
October 1, 2015
1.4 years
December 26, 2013
October 7, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
The change of Rheumatoid Arthritis (RA) associated symptoms and signs
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
- +2 more secondary outcomes
Study Arms (3)
High dose group
EXPERIMENTALFang 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
EXPERIMENTALFang 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 COMPARATORplacebo,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.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
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
Second affiliated hospital of Tianjin university of tcm
Tianjin, Tianjin Municipality, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
wei liu
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 26, 2013
First Posted
January 8, 2014
Study Start
March 1, 2014
Primary Completion
August 1, 2015
Last Updated
October 9, 2015
Record last verified: 2015-10