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

M

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

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

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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