NCT01774877

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
304

participants targeted

Target at P75+ for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Jul 2013

Shorter than P25 for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 24, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

December 19, 2014

Status Verified

December 1, 2014

Enrollment Period

11 months

First QC Date

January 22, 2013

Last Update Submit

December 17, 2014

Conditions

Rheumatoid Arthritis

Keywords

xinfeng capsule;rheumatoid arthritis (RA);randomized;double-blind;

Outcome Measures

Primary Outcomes (1)

  • ACR20 (American College of Rheumatology (ACR) criteria of 20% improvement in symptoms )

    ACR20 used for evaluating the efficacy of rheumatoid arthritis (RA).

    baseline,week4,week8,week12

Secondary Outcomes (7)

  • ACR50 (American College of Rheumatology (ACR) criteria of 50% improvement in symptoms )

    baseline,week4,week8，week12

  • ACR70 (American College of Rheumatology (ACR) criteria of 70% improvement in symptoms )

    baseline,week4,week8，week12

  • Patterns based on Chinese medicine(CM)symptoms

    baseline,week4,week8，week12

  • Disease Activity Scale (DAS)28

    baseline,week4,week8, week12

  • Rheumatoid arthritis (RA) biomarkers

    baseline, week12

  • +2 more secondary outcomes

Study Arms (2)

Xinfeng capsule & placebo

EXPERIMENTAL

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

leflunomide & placebo

ACTIVE COMPARATOR

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

Interventions

Xinfeng capsuleDRUG

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

Xinfeng capsule & placebo
leflunomideDRUG

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

leflunomide & placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The first affiliated hospital of bengbu medical college

Bengbu, Anhui, 233004, China

Location

The first affiliated hospital of anhui medical university

Hefei, Anhui, 230031, China

Location

Yijishan Hospital of Wannan Medical College

Wuhu, Anhui, 241001, China

Location

Related Publications (2)

  • Liu J, Wang Y, Huang C, Xu J, Li Z, Xu L, He L, Sun Y, Wang Y, Xu S, Zhao P, Mao T, Tan B, Zhu F, Zhang P, Fang L. Efficacy and safety of Xinfeng capsule in patients with rheumatoid arthritis: a multi-center parallel-group double-blind randomized controlled trial. J Tradit Chin Med. 2015 Oct;35(5):487-98. doi: 10.1016/s0254-6272(15)30130-8.

    PMID: 26591677DERIVED

  • Liu J, Huang CB, Wang Y, Xu GQ, Cheng YY, Feng YX, Liu L, Qi YJ. Chinese herbal medicine Xinfeng Capsule in treatment of rheumatoid arthritis: study protocol of a multicenter randomized controlled trial. J Integr Med. 2013 Nov;11(6):428-34. doi: 10.3736/jintegrmed2013059.

    PMID: 24299607DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

xinfengLeflunomide

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

IsoxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • liu jiu, doctor

    The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor，Chief Physician

Study Record Dates

First Submitted

January 22, 2013

First Posted

January 24, 2013

Study Start

July 1, 2013

Primary Completion

June 1, 2014

Study Completion

August 1, 2014

Last Updated

December 19, 2014

Record last verified: 2014-12

Locations

CN(3)