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

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Xinfeng capsule

leflunomide

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring xinfeng capsule;, rheumatoid arthritis (RA);, randomized;, double-blind;

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The first affiliated hospital of bengbu medical college
The first affiliated hospital of anhui medical university
Yijishan Hospital of Wannan Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Xinfeng capsule & placebo

leflunomide & placebo

Arm Description

Xinfeng capsule:Three each time, 3 times a day, Oral,for 3 months placebo(for leflunomide): 10 mg each time, 1 time a day, Oral,for3 months

leflunomide :10mg each time, one time a day, by mouth,for 3 months placebo(for xinfeng capsule):Three each time, 3 times a day, Oral,for3 months

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

ACR50 used for evaluating the efficacy of rheumatoid arthritis (RA).

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

ACR50 used for evaluating the efficacy of rheumatoid arthritis (RA).

Patterns based on Chinese medicine(CM)symptoms

Disease Activity Scale (DAS)28

Rheumatoid arthritis (RA) biomarkers

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

Life Quality Assessment

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.

x-rays of the hands and wrists

Full Information

NCT ID

NCT01774877

First Posted

January 22, 2013

Last Updated

December 17, 2014

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

1. Study Identification

Unique Protocol Identification Number

NCT01774877

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

July 2013 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the 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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

304 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Xinfeng capsule & placebo

Arm Type

Experimental

Arm Description

Xinfeng capsule:Three each time, 3 times a day, Oral,for 3 months placebo(for leflunomide): 10 mg each time, 1 time a day, Oral,for3 months

Arm Title

leflunomide & placebo

Arm Type

Active Comparator

Arm Description

leflunomide :10mg each time, one time a day, by mouth,for 3 months placebo(for xinfeng capsule):Three each time, 3 times a day, Oral,for3 months

Intervention Type

Drug

Intervention Name(s)

Xinfeng capsule

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

leflunomide

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

baseline,week4,week8,week12

Secondary Outcome Measure Information:

Title

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

Description

ACR50 used for evaluating the efficacy of rheumatoid arthritis (RA).

Time Frame

baseline,week4,week8，week12

Title

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

Description

ACR50 used for evaluating the efficacy of rheumatoid arthritis (RA).

Time Frame

baseline,week4,week8，week12

Title

Patterns based on Chinese medicine(CM)symptoms

Time Frame

baseline,week4,week8，week12

Title

Disease Activity Scale (DAS)28

Time Frame

baseline,week4,week8, week12

Title

Rheumatoid arthritis (RA) biomarkers

Description

Time Frame

baseline, week12

Title

Life Quality Assessment

Description

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.

Time Frame

baseline,week12

Title

x-rays of the hands and wrists

Time Frame

baseline,week12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

liu jiu, doctor

Organizational Affiliation

The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

The first affiliated hospital of bengbu medical college

City

Bengbu

State/Province

Anhui

ZIP/Postal Code

233004

Country

China

Facility Name

The first affiliated hospital of anhui medical university

City

Hefei

State/Province

Anhui

ZIP/Postal Code

230031

Country

China

Facility Name

Yijishan Hospital of Wannan Medical College

City

Wuhu

State/Province

Anhui

ZIP/Postal Code

241001

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

26591677

Citation

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.

Results Reference

derived

PubMed Identifier

24299607

Citation

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.

Results Reference

derived

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

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