Clinical trial NCT02029599: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Maoxiang Group Jilin Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-01-08
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The percentage of Therapeutic effect with American College of Rheumatology standards (ACR)
timeFrame: Taken at day 1 (baseline) and Change from Baseline in 4th,8th,12th week
Secondary outcomes:
measure: The change of Rheumatoid Arthritis (RA) associated symptoms and signs
timeFrame: Taken at day 1 (baseline) and Change from Baseline in 4th,8th,12th week
measure: Safety assessments will be based on adverse event reports and the results of vital sign measurements, electrocardiogram, physical examinations, and clinical laboratory tests
timeFrame: Taken at day 1 (baseline) and Change from Baseline in 4th,8th,12th week
measure: 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).
timeFrame: Taken at day 1 (baseline) and Change from Baseline in 4th,8th,12th week
measure: The change of laboratory test indexes (ESR、RF、CRP)
timeFrame: baseline,week12
measure: Traditional Chinese Medicine(TCM) characteristics evaluative index: Traditional Chinese medicine Syndrome Scale
timeFrame: Taken at day 1 (baseline) and Change from Baseline in 4th,8th,12th week
measure: The score of clinical symptoms and symptom integral
timeFrame: Taken at day 1 (baseline) and Change from Baseline in 4th,8th,12th week
measure: Change in the days and doses using of analgesic(Paracetamol Tablets)
timeFrame: Taken at day 1 (baseline) and Change from Baseline in 4th,8th,12th week
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Hubei provincial hospital of tcm
state: Hubei
city: Shenyang
country: China
facility: Hospital of Liaoning University of Traditional Chinese Medicine
state: Liaoning
city: Shanghai
country: China
facility: LONGHUA Hospital Shanghai University of TCM
state: Shanghai
city: Tianjin
country: China
facility: First Teaching hospital of Tianjin University of Traditional Chinese Medicine
state: Tianjin
city: Tianjin
country: China
facility: Second affiliated hospital of Tianjin university of tcm
state: Tianjin
Study officials:
affiliation: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
name: wei liu
role: PRINCIPAL_INVESTIGATOR
References: