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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02029599
Recruitment Status : Completed
First Posted : January 8, 2014
Last Update Posted : October 9, 2015
Sponsor:
Information provided by (Responsible Party):
Maoxiang Group Jilin Pharmaceutical Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Fang yi qing feng shi granule Drug: placebo Drug: Methotrexate Drug: Acetaminophen tablets Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : March 2014
Actual Primary Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High dose group
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.
Drug: Fang yi qing feng shi granule
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

Experimental: Low dose group

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.

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

Placebo Comparator: The placebo group
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.
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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02029599


Locations
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China, Hubei
Hubei provincial hospital of tcm
Wuhan, Hubei, China
China, Liaoning
Hospital of Liaoning University of Traditional Chinese Medicine
Shenyang, Liaoning, China
China, Shanghai
LONGHUA Hospital Shanghai University of TCM
Shanghai, Shanghai, China
China, Tianjin
First Teaching hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin, China
Second affiliated hospital of Tianjin university of tcm
Tianjin, Tianjin, China
Sponsors and Collaborators
Maoxiang Group Jilin Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: wei liu First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

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Responsible Party: Maoxiang Group Jilin Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02029599    
Other Study ID Numbers: China.JLMXFYQ2008-01
First Posted: January 8, 2014    Key Record Dates
Last Update Posted: October 9, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Acetaminophen
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antipyretics