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Rheumatoid ArthritisNCT01774877

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

A study testing Xinfeng capsule and leflunomide in people with Rheumatoid Arthritis, run by The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine at 3 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Xinfeng capsule and leflunomide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
304 participants
Where
3 sitesChina
Study dates
Jul 2013to Aug 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • The first affiliated hospital of bengbu medical college

    Bengbu, Anhui, 233004

  • The first affiliated hospital of anhui medical university

    Hefei, Anhui, 230031

  • Yijishan Hospital of Wannan Medical College

    Wuhu, Anhui, 241001

Other trials in China

About this study

Official title: 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.

Being tested
Xinfeng capsule, leflunomide
Keywords
xinfeng capsule;, rheumatoid arthritis (RA);, randomized;, double-blind;
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

  • 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

Study groups in NCT01774877
Study groupRoleWhat they receive
Xinfeng capsule & placeboExperimental1. 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
Receives: Drug: Xinfeng capsule
leflunomide & placeboActive comparator1. 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
Receives: Drug: leflunomide

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: baseline,week4,week8,week12

Secondary outcomes (7)

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

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

    Measured: baseline,week4,week8，week12

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

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

    Measured: baseline,week4,week8，week12

  3. Patterns based on Chinese medicine(CM)symptoms

    Measured: baseline,week4,week8，week12

  4. Disease Activity Scale (DAS)28

    Measured: baseline,week4,week8, week12

  5. 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

    Measured: baseline, week12

  6. 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.

    Measured: baseline,week12

  7. x-rays of the hands and wrists

    Measured: baseline,week12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionJun 2014
  4. Study completionAug 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
304 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01774877
Sponsor's protocol ID
2012BAI26B02
Status last verified
Dec 2014
First submitted
22 Jan 2013
Last updated
19 Dec 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26591677

  • 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.

    PubMed 24299607

Questions about this trial

What is this clinical trial studying?

A study testing Xinfeng capsule and leflunomide in people with Rheumatoid Arthritis, run by The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ACR20 (American College of Rheumatology (ACR) criteria of 20% improvement in symptoms ) (time frame: baseline,week4,week8,week12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01774877, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2014.

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