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Rheumatoid ArthritisPhase 2NCT02029599

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

A Phase 2 study testing Fang yi qing feng shi granule, Methotrexate and Acetaminophen tablets in people with Rheumatoid Arthritis, run by Maoxiang Group Jilin Pharmaceutical Co., Ltd. at 5 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

The aim of this study is to evaluate the efficacy and safety of Fang yi qing Feng shi granules in subjects with Rheumatoid Arthritis. 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?
Fang yi qing feng shi granule, Methotrexate and Acetaminophen tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
240 participants
Where
5 sitesChina
Study dates
Mar 2014to Aug 2015
Phase
Phase 2
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

  • Subjects have the diagnosis of Rheumatoid Arthritis in active state.
  • Subjects have the Traditional Chinese Medicine (TCM) diagnosis ofArthralgic Syndrome with the sign of dampness obstructing connecting vessel。
  • Subjects must stop the medicine at least three month，which is Diseases modifying anti-rheumatic drugs(including glucocorticoids).
  • Male or female subjects, between the ages of 18 and 65 years old.
  • Joint function grading and ray classification are both in Ⅰ～Ⅲ.
  • Subjects agree to participate in this study and sign the informed consent form.

Who cannot join

  • Subjects with systemic lupus erythematosus,sicca syndrome, or severe osteoarthropathy will be excluded.
  • Subjects with severe rheumatic arthritis are loss of ability
  • Allergic to test drugs(basic treatment or drug combination),Allergic constitution(Allergic to two or more drugs).
  • Female subject who was pregnant or breast-feeding or considering becoming pregnant.
  • Subjects with sever diseases in Cardiovascular, brain, lung, liver, kidney and hematopoietic system.
  • The Liver function (ALT,AST) and kidney function（BUN,Cr）is higher than normal.
  • The Blood Routine (leukocyte count,platelet count)is lower than normal.
  • Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

China5 sites

  • LONGHUA Hospital Shanghai University of TCM

    Shanghai, Shanghai Municipality

  • Hospital of Liaoning University of Traditional Chinese Medicine

    Shenyang, Liaoning

  • First Teaching hospital of Tianjin University of Traditional Chinese Medicine

    Tianjin, Tianjin Municipality

  • Second affiliated hospital of Tianjin university of tcm

    Tianjin, Tianjin Municipality

  • Hubei provincial hospital of tcm

    Wuhan, Hubei

Other trials in China

About this study

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

The aim of this study is to evaluate the efficacy and safety of Fang yi qing Feng shi granules in subjects with Rheumatoid Arthritis.

Read the 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.

Being tested
Fang yi qing feng shi granule, placebo, Methotrexate, Acetaminophen tablets
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • Fang yi qing feng shi granuleDrug

    10g, Oral,Three each time, 3 times a day,for 3 months;

  • placeboDrug

    10g, Oral,Three each time, 3 times a day,for 3 months

  • MethotrexateDrug

    7.5-15mg per week，All patients should be used

  • Acetaminophen tabletsDrug

    Oral,0.5g, 1~2 times a day, when vas=10

Study groups in NCT02029599
Study groupRoleWhat they receive
High dose groupExperimentalFang 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.
Receives: Drug: Fang yi qing feng shi granule; Drug: Methotrexate; Drug: Acetaminophen tablets
Low dose groupExperimentalFang 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.
Receives: Drug: Fang yi qing feng shi granule; Drug: placebo; Drug: Methotrexate; Drug: Acetaminophen tablets
The placebo groupPlacebo comparatorplacebo,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.
Receives: Drug: placebo; Drug: Methotrexate; Drug: Acetaminophen tablets

What is being measured

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

  1. The percentage of Therapeutic effect with American College of Rheumatology standards (ACR)

    Measured: Taken at day 1 (baseline) and Change from Baseline in 4th,8th,12th week

Secondary outcomes (7)

  1. The change of Rheumatoid Arthritis (RA) associated symptoms and signs

    The symptoms and signs include "Tender joint count,swollen joint count,time of morning stiffness,mean grip strength, VAS score,Jint function"

    Measured: Taken at day 1 (baseline) and Change from Baseline in 4th,8th,12th week

  2. Safety assessments will be based on adverse event reports and the results of vital sign measurements, electrocardiogram, physical examinations, and clinical laboratory tests

    Measured: 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).

    Measured: Taken at day 1 (baseline) and Change from Baseline in 4th,8th,12th week

  4. The change of laboratory test indexes (ESR、RF、CRP)

    Measured: baseline,week12

  5. Traditional Chinese Medicine(TCM) characteristics evaluative index: Traditional Chinese medicine Syndrome Scale

    Measured: Taken at day 1 (baseline) and Change from Baseline in 4th,8th,12th week

  6. The score of clinical symptoms and symptom integral

    Measured: 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)

    Measured: Taken at day 1 (baseline) and Change from Baseline in 4th,8th,12th week

Timeline

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

  1. First posted8 Jan 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionAug 2015

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02029599
Sponsor's protocol ID
China.JLMXFYQ2008-01
Status last verified
Oct 2015
First submitted
26 Dec 2013
Last updated
9 Oct 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fang yi qing feng shi granule, Methotrexate and Acetaminophen tablets in people with Rheumatoid Arthritis, run by Maoxiang Group Jilin Pharmaceutical Co., Ltd. at 5 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 6 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 9 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

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). 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 NCT02029599.

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 9 Oct 2015.

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