Rheumatoid Arthritis Clinical Trial
Official title:
A Clinical Study of a Natural Remedy for Rheumatoid Arthritis vs. Commonly Used Conventional Medications
The purpose of this study is to evaluate the efficacy and safety of a combined therapy for rheumatoid arthritis (RA). The combined therapy contained paeoniflorin (Brand name: Pafulin), which has anti-inflammation properties, and Cervus and Cucumis polypeptide injection (Brand name: Songmeile), which has bone healing, pain relieving, and anti-inflammation properties. The hypothesis is that this remedy, which has long been used by the world's largest RA community, is effective and safe when tested by modern clinical standards and criteria.
Status | Completed |
Enrollment | 1748 |
Est. completion date | March 2012 |
Est. primary completion date | April 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - age of 18 years or older - active RA, defined by at least 8 swollen joints and at least 10 tender joints (excluding distal interphalangeal joints) - an erythrocyte sedimentation rate (ESR) of at least 28 mm per hour - the 1987 revised American College of Rheumatology (ACR) criteria for diagnosis of RA for at least 6 months - not use of NSAIDs within two weeks - agreement to participate in this study. Exclusion Criteria: - poor compliance - severe medical conditions - abnormalities in liver, or kidney function, or in haematological parameters, - pregnancy or breast feeding |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Beijing Friendship Hospital, Affiliated to Capital Medical University | Beijing | |
China | Institute of Chinese Medical Sciences, University of Macau | Taipa |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota - Clinical and Translational Science Institute |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The relief of rheumatoid arthritis symptoms and the improvement of functions assessed by the American College of Rheumatology (ACR) core set measures. | The American College of Rheumatology (ACR) core set measure improvement % response rate was used to assess the relief of rheumatoid arthritis symptoms and the improvement of functions. | CCPI: 2 weeks + 2 weeks with 1 week in between. All other drugs: at least 12 months. | No |
Secondary | The adverse effects associated with the treatments | The following parameters were used to measure the safety of the treatments: Headache, Up resp infection, Urinary tract infection, Other infection, Nausea, Rash, Diarrhea, Fatigue, Alopecia, Rhinitis, Dizziness, Abdominal pain, Sinusitis, Mouth ulcer, Hypertension, Dyspepsia, Vomiting, Insomnia, ALT elevation, AST elevation, WBC decrease, Glucose elevation, etc. | CCPI: 2 weeks + 2 weeks with 1 week in between. All other drugs: at least 12 months. | No |
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