A Clinical Study of Xin'an Medicine in the Treatment of Bi Syndrome

December 17, 2014 updated by: Liu Jian, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Efficacy and Safety of Xinfeng Capsule in the Treatment of Rheumatoid Arthritis (RA):A Randomized, Double-blind, Double-dummy, Multi-center Trial

Bi Syndrome is one of Traditional Chinese Medicine（TCM）name, It means an obstruction in Chinese,and it refers the syndrome characterized by the obstruction of qi and blood in the meridians due to the invasion of external pathogenic wind,cold and dampness, manifested as soreness, pain, numb,etc. Bi Syndrome contains Rheumatoid arthritis(RA). RA is a chronic disease affecting more than 20 million people in the world.It is one of the most common forms of autoimmune disease. Xin'an Medicine is one of Traditional Chinese Medicine which originated from AnHui. Xinfeng Capsule developed according to the Xin'an medicine theory ,and it has long been adopted for treatment of rheumatoid arthritis (RA). The study is aimed to evaluate the effectiveness and safety of Xinfeng Capsule in the treatment of RA.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

304

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Bengbu, Anhui, China, 233004
        • The First Affiliated Hospital of Bengbu Medical College
      • Hefei, Anhui, China, 230031
        • The First Affiliated Hospital of Anhui Medical University
      • Wuhu, Anhui, China, 241001
        • Yijishan Hospital of Wannan Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of RA, classified by American Rheumatism Association 1987 revised criteria.
  • According with the Zheng diagnosis of Traditional Chinese Medicine.
  • age from 18 to 65 years.
  • For patients currently receiving non-steroidal anti-inflammatory drugs (NSAIDs): Treatment at a stable dose during last 4 weeks prior to screening，or Patients do not take NSAIDs at least 1 weeks prior to screening.
  • Patients not taking DMARDs at least 4 weeks prior to screening.
  • Patients taking corticosteroids (≤15mg prednisone or Equivalent) ≥4 weeks before entering the trial.
  • Patients agree to participate in this study and sign the informed consent form.

Exclusion Criteria:

  • Patients have received intra-articular or systemic corticosteroid injection within 4 weeks of screening.
  • Patients have high disease activity (DAS28-3 scores> 5.1).
  • Patients have diagnosed any other chronic inflammatory disease or connective tissue disease like sicca syndrome（SS）, systemic lupus erythematosus (SLE)etc;
  • Patients with sever diseases in Cardiovascular, brain, lung, liver, kidney and hematopoietic system ;
  • Patients who are pregnant or nursing mothers or Psychiatric patients.
  • Patients with active gastroduodenal ulcer or gastritis which caused by long-term use of NSAIDs;
  • The patient who has known hypersensitivity to trial medicine .
  • Patients have participated in other clinical trials within 4 weeks of screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Xinfeng capsule & placebo
  1. Xinfeng capsule:Three each time, 3 times a day, Oral,for 3 months
  2. placebo(for leflunomide): 10 mg each time, 1 time a day, Oral,for3 months
Drug: Xinfeng capsule
Xinfeng capsule:Three each time, 3 times a day, Oral,for 3 months; placebo(for leflunomide):10mg each time, 1 time a day, Oral,for 3 months; Participants will continue on the stable dose of glucocorticoids and NSAIDs that they were receiving prior to study entry
Active Comparator: leflunomide & placebo
  1. leflunomide :10mg each time, one time a day, by mouth,for 3 months
  2. placebo(for xinfeng capsule):Three each time, 3 times a day, Oral,for3 months
Drug: leflunomide
leflunomide :10mg each time, one time a day, Oral,for 3 months; placebo(for xinfeng capsule):Three each time, 3 times a day, Oral,for 3 months; Participants will continue on the stable dose of glucocorticoids and NSAIDs that they were receiving prior to study entry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ACR20 (American College of Rheumatology (ACR) criteria of 20% improvement in symptoms )
Time Frame: baseline,week4,week8,week12
ACR20 used for evaluating the efficacy of rheumatoid arthritis (RA).
baseline,week4,week8,week12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ACR50 (American College of Rheumatology (ACR) criteria of 50% improvement in symptoms )
Time Frame: baseline,week4,week8，week12
ACR50 used for evaluating the efficacy of rheumatoid arthritis (RA).
baseline,week4,week8，week12
ACR70 (American College of Rheumatology (ACR) criteria of 70% improvement in symptoms )
Time Frame: baseline,week4,week8，week12
ACR50 used for evaluating the efficacy of rheumatoid arthritis (RA).
baseline,week4,week8，week12
Patterns based on Chinese medicine(CM)symptoms
Time Frame: baseline,week4,week8，week12
baseline,week4,week8，week12
Disease Activity Scale (DAS)28
Time Frame: baseline,week4,week8, week12
baseline,week4,week8, week12
Rheumatoid arthritis (RA) biomarkers
Time Frame: baseline, week12
Rheumatoid arthritis (RA) biomarkers,including rheumatoid factor (RF), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) ,anti-cyclic citrullinated peptide (anti-CCP) antibodies, IgG、IgA、IgM, d-dimer, the coagulation function tests
baseline, week12
Life Quality Assessment
Time Frame: baseline,week12
Life Quality Assessment,including Health Assessment Questionnaire (HAQ), Self-rating depression scale(SDS), Self-rating anxiety scale(SAS),quality of life Questionnaire with rheumatoid arthritis.
baseline,week12
x-rays of the hands and wrists
Time Frame: baseline,week12
baseline,week12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Collaborators

Ministry of Science and Technology of the People´s Republic of China

Investigators

  • Principal Investigator: liu jiu, doctor, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

January 22, 2013

First Submitted That Met QC Criteria

January 22, 2013

First Posted (Estimate)

January 24, 2013

Study Record Updates

Last Update Posted (Estimate)

December 19, 2014

Last Update Submitted That Met QC Criteria

December 17, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012BAI26B02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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