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

Maoxiang Group Jilin Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: Acetaminophen tablets; Drug: Fang yi qing feng shi granule; Drug: Methotrexate; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02029599

China.JLMXFYQ2008-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 240 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 3 patient groups, including a placebo group

High dose group

Experimental group

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.

Treatment:

Drug: Acetaminophen tablets

Drug: Fang yi qing feng shi granule

Drug: Methotrexate

Low dose group

Experimental group

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.

Treatment:

Drug: Acetaminophen tablets

Drug: Fang yi qing feng shi granule

Drug: Methotrexate

Drug: placebo

The placebo group

Placebo Comparator group

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.

Treatment:

Drug: Acetaminophen tablets

Drug: Methotrexate

Drug: placebo