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

Primary Purpose

Rheumatoid Arthritis

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Treatment of MTX and HCQ
Treatment of TCM
Integrative Medicine
Sponsored by
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Guang'anmen Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Treatment of MTX and HCQ

Treatment of TCM

Integrative Medicine

Arm Description

Patients were treated with methotrexate (MTX), hydroxychloroquine (HCQ), oral Qingre Huoxue granule placebo and Qingre Huoxue external preparation placebo.

Patients were treated with oral Qingre Huoxue granule, Qingre Huoxue external preparation, methotrexate placebo and hydroxychloroquine placebo.

The patients were treated with methotrexate, hydroxychloroquine, oral Qingre Huoxue granule and Qingre Huoxue external preparation.

Outcomes

Primary Outcome Measures

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])

Secondary Outcome Measures

The proportion of patients achieving ACR20/50/70
ACR20/50/70 is referred to American College of Rheumatology Criteria.
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
The change in Sharp score
The change in X-Ray from baseline to week 52.
The change in OMERACT RAMRIS score
The change in Magnetic Resonance Imaging from baseline to week 24.
The number of adverse events
The number of adverse events that are related to treatment

Full Information

First Posted
August 26, 2015
Last Updated
June 17, 2016
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02551575
Brief Title
Efficacy and Safety of Traditional Chinese Medicine (TCM) Comprehensive Therapy in Patients With Rheumatoid Arthritis
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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). 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.
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
468 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment of MTX and HCQ
Arm Type
Active Comparator
Arm Description
Patients were treated with methotrexate (MTX), hydroxychloroquine (HCQ), oral Qingre Huoxue granule placebo and Qingre Huoxue external preparation placebo.
Arm Title
Treatment of TCM
Arm Type
Experimental
Arm Description
Patients were treated with oral Qingre Huoxue granule, Qingre Huoxue external preparation, methotrexate placebo and hydroxychloroquine placebo.
Arm Title
Integrative Medicine
Arm Type
Experimental
Arm Description
The patients were treated with methotrexate, hydroxychloroquine, oral Qingre Huoxue granule and Qingre Huoxue external preparation.
Intervention Type
Drug
Intervention Name(s)
Treatment of MTX and HCQ
Other Intervention Name(s)
Treatment of MTX, HCQ and Qingre Huoxue placebo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Treatment of TCM
Other Intervention Name(s)
Qingre Huoxue medicines，MTX placebo and HCQ placebo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Integrative Medicine
Other Intervention Name(s)
Treatment of Qingre Huoxue medicines，MTX and HCQ
Intervention Description
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.
Primary Outcome Measure Information:
Title
The change from Baseline to week 24 in Disease Activity Score (DAS28)
Description
Disease Activity Score for 28-joint counts was based on the erythrocyte sedimentation rate(ESR) (DAS28-4[ESR])
Time Frame
0 weeks, 12 weeks, 24 weeks
Secondary Outcome Measure Information:
Title
The proportion of patients achieving ACR20/50/70
Description
ACR20/50/70 is referred to American College of Rheumatology Criteria.
Time Frame
0 week, 12 weeks, 24 weeks
Title
The change from baseline to week 24 in the score on the patient report outcome (PRO)
Description
PRO scores ranges from 0 to 3, with higher scores indicating greater disability
Time Frame
0 week, 12 weeks, 24 weeks
Title
The change in Sharp score
Description
The change in X-Ray from baseline to week 52.
Time Frame
0 week, 52 weeks
Title
The change in OMERACT RAMRIS score
Description
The change in Magnetic Resonance Imaging from baseline to week 24.
Time Frame
0 week, 24 weeks
Title
The number of adverse events
Description
The number of adverse events that are related to treatment
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiang Quan, MD
Organizational Affiliation
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Guang'anmen Hospital
City
Bei Jing
State/Province
Beijing
ZIP/Postal Code
100052
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
34113254
Citation
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.
Results Reference
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Efficacy and Safety of Traditional Chinese Medicine (TCM) Comprehensive Therapy in Patients With Rheumatoid Arthritis

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