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NCT Number: NCT02029599

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

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

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hubei provincial hospital of tcm, Wuhan, Hubei, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fang yi qing feng shi granule

Drug

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

Placebo

Drug

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

methotrexate

Drug

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

Acetaminophen tablets

Drug

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

Primary outcomes

  1. The percentage of Therapeutic effect with American College of Rheumatology standards (ACR)

    Time frame: Taken at day 1 (baseline) and Change from Baseline in 4th,8th,12th week

Secondary outcomes

  1. The change of Rheumatoid Arthritis (RA) associated symptoms and signs

    Time frame: Taken at day 1 (baseline) and Change from Baseline in 4th,8th,12th week

    The symptoms and signs include "Tender joint count,swollen joint count,time of morning stiffness,mean grip strength, VAS score,Jint function"

  2. Safety assessments will be based on adverse event reports and the results of vital sign measurements, electrocardiogram, physical examinations, and clinical laboratory tests

    Time frame: Taken at day 1 (baseline) and Change from Baseline in 4th,8th,12th week

  3. 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).

    Time frame: Taken at day 1 (baseline) and Change from Baseline in 4th,8th,12th week

  4. The change of laboratory test indexes (ESR、RF、CRP)

    Time frame: baseline,week12

  5. Traditional Chinese Medicine(TCM) characteristics evaluative index: Traditional Chinese medicine Syndrome Scale

    Time frame: Taken at day 1 (baseline) and Change from Baseline in 4th,8th,12th week

  6. The score of clinical symptoms and symptom integral

    Time frame: Taken at day 1 (baseline) and Change from Baseline in 4th,8th,12th week

  7. Change in the days and doses using of analgesic(Paracetamol Tablets)

    Time frame: Taken at day 1 (baseline) and Change from Baseline in 4th,8th,12th week

Sponsors and collaborators

Lead sponsor

Maoxiang Group Jilin Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
First posted
Jan 8, 2014
Registry last updated
Oct 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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