Trial | NCT02029599  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    240
The aim of this study is to evaluate the efficacy and safety of Fang yi qing Feng shi granules in subjects with Rheumatoid Arthritis.
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 Started
Mar 31
2014
Primary Completion
Aug 31
2015
Last Update
Oct 09
2015
Estimate

Drug Fang yi qing feng shi granule

10g, Oral,Three each time, 3 times a day,for 3 months;

Drug placebo

10g, Oral,Three each time, 3 times a day,for 3 months

Drug Methotrexate

7.5-15mg per week，All patients should be used

Drug Acetaminophen tablets

Oral,0.5g, 1~2 times a day, when vas=10

High dose group Experimental

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 Experimental

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 Comparator

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.

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
No Results Posted