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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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27 June 2016 |
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Main ID: |
NCT02551575 |
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Date of registration:
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26/08/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy and Safety of Traditional Chinese Medicine (TCM) Comprehensive Therapy in Patients With Rheumatoid Arthritis
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Scientific title:
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Efficacy and Safety of Qingre Huoxue Comprehensive Therapy in the Treatment of Rheumatoid Arthritis (RA): A Randomized, Double-blind, Double-dummy, Multi-center Trial |
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Date of first enrolment:
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November 2014 |
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Target sample size:
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468 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02551575 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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China
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Contacts
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Name:
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Jiang Quan, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Guang'anmen Hospital of China Academy of Chinese Medical Sciences |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Drug: Treatment of MTX and HCQ
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Drug: Treatment of TCM
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Drug: Integrative Medicine
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Primary Outcome(s)
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The change from Baseline to week 24 in Disease Activity Score (DAS28)
[Time Frame: 0 weeks, 12 weeks, 24 weeks]
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Secondary Outcome(s)
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The number of adverse events
[Time Frame: 24 weeks]
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The change in OMERACT RAMRIS score
[Time Frame: 0 week, 24 weeks]
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The proportion of patients achieving ACR20/50/70
[Time Frame: 0 week, 12 weeks, 24 weeks]
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The change from baseline to week 24 in the score on the patient report outcome (PRO)
[Time Frame: 0 week, 12 weeks, 24 weeks]
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The change in Sharp score
[Time Frame: 0 week, 52 weeks]
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Secondary ID(s)
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2013BAI02B06
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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