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Rheumatoid ArthritisPhase 2/3NCT02551575

Efficacy and Safety of Traditional Chinese Medicine (TCM) Comprehensive Therapy in Patients With Rheumatoid Arthritis

A Phase 2/3 study testing Treatment of MTX and HCQ, Treatment of TCM and Integrative Medicine in people with Rheumatoid Arthritis, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is prospective randomized, controlled study to evaluate the efficacy and safety of Qingre Huoxue comprehensive therapy in treating of patients with early Rheumatoid Arthritis (RA). 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?
Treatment of MTX and HCQ, Treatment of TCM and Integrative Medicine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
468 participants
Where
1 siteChina
Study dates
Nov 2014to Dec 2017
Phase
Phase 2/3
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

  • Diagnosed with rheumatoid arthritis as determined by the 1987 ACR classification criteria.
  • Diagnosed with TCM dampness heat and blood stasis syndrome
  • The course of RA is not more than 5 years.
  • Swollen joint (SJC)≥2 and tender joint count(TJC)≥3.
  • Erythrocyte Sedimentation Rate（ESR）≥20 mm/hr
  • Patients who take disease-modifying antirheumatic drugs for at least 3 months on a stable dose, and retain the same treatment during the study.
  • Age 18-65 years with informed consent

Who cannot join

  • Patients with skin burst or allergies.
  • Patients with cancer or other malignant disease such as cardiovascular, hematopoietic, liver and kidney disease, and psychopath
  • Active or chronic infection, including HIV, hepatitis C virus, hepatitis B virus, tuberculosis
  • Previous treated with tripterygii, glucocorticoid or biologic disease-modifying antirheumatic drug (DMARD) in 3 months.
  • Previous treated with MTX or HCQ
  • Patients with retinopathy.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Guang'anmen Hospital

    Beijing, Beijing Municipality, 100052

Other trials in China

About this study

Official title: Efficacy and Safety of Qingre Huoxue Comprehensive Therapy in the Treatment of Rheumatoid Arthritis (RA): A Randomized, Double-blind, Double-dummy, Multi-center Trial

This is prospective randomized, controlled study to evaluate the efficacy and safety of Qingre Huoxue comprehensive therapy in treating of patients with early Rheumatoid Arthritis (RA). The major outcome index is the change from baseline to week 24 in Disease Activity Score (DAS28), and minor outcome indexes include American College of Rheumatology (ACR)20/50/70, PRO score, Sharp score and OMERACT RAMRIS score. The adverse events at any time were recorded to evaluate the safety.

Read the detailed description

Three arms were included in this study, and treatment with MTX and HCQ is defined as active comparator. Treatment of TCM，including Qingre Huoxue granule, Qingre Huoxue external preparation, MTX placebo and HCQ placebo, is defined as one experimental arm. Treatment of integrative medicine，including Qingre Huoxue granule, Qingre Huoxue external preparation, MTX and HCQ, is defined as another experimental arm.

Being tested
Treatment of MTX and HCQ, Treatment of TCM, Integrative Medicine
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • Treatment of MTX and HCQDrug

    Also called Treatment of MTX, HCQ and Qingre Huoxue placebo

    Methotrexate: 10-15mg per week according to patient's weight, oral, for 24 weeks.

    Hydroxychloroquine: 200mg, 2 times a day, oral, for 24 weeks. Qingre Huoxue granule placebo: 10g, 2 times a day, oral, for 24 weeks. Qingre Huoxue external preparation placebo: 20g, 1 times a day, external, for 4 weeks, then 10g, 1 times a day, external, for 8 weeks.

  • Treatment of TCMDrug

    Also called Qingre Huoxue medicines，MTX placebo and HCQ placebo

    Qingre Huoxue granule: 10g, 2 times a day, oral, for 24 weeks. Qingre Huoxue external preparation: 20g, 1 times a day, external, for 4 weeks, then 10g, 1 times a day, external, for 8 weeks.

    Methotrexate placebo: 10-15mg per week according to patient's weight, oral, for 24 weeks.

    Hydroxychloroquine placebo: 200mg, 3 times a day, oral, for 24 weeks.

  • Integrative MedicineDrug

    Also called Treatment of Qingre Huoxue medicines，MTX and HCQ

    Qingre Huoxue granule: 10g, 2 times a day, oral, for 24 weeks. Qingre Huoxue external preparation: 20g, 1 times a day, external, for 4 weeks, then 10g, 1 times a day, external, for 8 weeks.

    Methotrexate: 10-15mg per week according to patient's weight, oral, for 24 weeks.

    Hydroxychloroquine: 200mg, 3 times a day, oral, for 24 weeks.

Study groups in NCT02551575
Study groupRoleWhat they receive
Treatment of MTX and HCQActive comparatorPatients were treated with methotrexate (MTX), hydroxychloroquine (HCQ), oral Qingre Huoxue granule placebo and Qingre Huoxue external preparation placebo.
Receives: Drug: Treatment of MTX and HCQ
Treatment of TCMExperimentalPatients were treated with oral Qingre Huoxue granule, Qingre Huoxue external preparation, methotrexate placebo and hydroxychloroquine placebo.
Receives: Drug: Treatment of TCM
Integrative MedicineExperimentalThe patients were treated with methotrexate, hydroxychloroquine, oral Qingre Huoxue granule and Qingre Huoxue external preparation.
Receives: Drug: Integrative Medicine

What is being measured

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

  1. The change from Baseline to week 24 in Disease Activity Score (DAS28)

    Disease Activity Score for 28-joint counts was based on the erythrocyte sedimentation rate(ESR) (DAS28-4[ESR])

    Measured: 0 weeks, 12 weeks, 24 weeks

Secondary outcomes (5)

  1. The proportion of patients achieving ACR20/50/70

    ACR20/50/70 is referred to American College of Rheumatology Criteria.

    Measured: 0 week, 12 weeks, 24 weeks

  2. The change from baseline to week 24 in the score on the patient report outcome (PRO)

    PRO scores ranges from 0 to 3, with higher scores indicating greater disability

    Measured: 0 week, 12 weeks, 24 weeks

  3. The change in Sharp score

    The change in X-Ray from baseline to week 52.

    Measured: 0 week, 52 weeks

  4. The change in OMERACT RAMRIS score

    The change in Magnetic Resonance Imaging from baseline to week 24.

    Measured: 0 week, 24 weeks

  5. The number of adverse events

    The number of adverse events that are related to treatment

    Measured: 24 weeks

Timeline

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

  1. First posted16 Sep 2015 (estimated)
  2. Study startNov 2014
  3. Primary completionJun 2017 (estimated)
  4. Study completionDec 2017 (estimated)

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
468 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02551575
Sponsor's protocol ID
2013BAI02B06
Status last verified
Jun 2016
First submitted
26 Aug 2015
Last updated
20 Jun 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Gong X, Liu WX, Tang XP, Wang J, Liu J, Huang QC, Liu W, Fang YF, He DY, Liu Y, Gao ML, Wu QJ, Chen S, Li ZB, Wang Y, Xie YM, Zhang JL, Zhou CY, Ma L, Wang XC, Zhang C, Jiang Q. Traditional Chinese Medicine Qingre Huoxue Treatment vs. the Combination of Methotrexate and Hydroxychloroquine for Active Rheumatoid Arthritis: A Multicenter, Double-Blind, Randomized Controlled Trial. Front Pharmacol. 2021 May 25;12:679588. doi: 10.3389/fphar.2021.679588. eCollection 2021.

    PubMed 34113254

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Treatment of MTX and HCQ, Treatment of TCM and Integrative Medicine in people with Rheumatoid Arthritis, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site 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 6 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: status not confirmed, as of the sponsor's last update on 20 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

What does this combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Results are not available in the source record.

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 change from Baseline to week 24 in Disease Activity Score (DAS28) (time frame: 0 weeks, 12 weeks, 24 weeks). 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 NCT02551575, which also lists 1 linked publication.

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 20 Jun 2016.

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