Rheumatoid Arthritis
Conditions
Brief summary
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.
Detailed description
This is a double-blinded randomized study on the treatment of rheumatoid arthritis. In particular, patients were randomly assigned to one of the following treatment groups: Paeoniflorin (PAE) + Cervus and Cucumis polypeptide injection (CCPI), Methotrexate (MTX) + Leflunomide (LEF), and MTX + LEF + CCPI. The therapeutic effectiveness was evaluated by the 7 core set measures of American College of Rheumatology (ACR). Adverse effects, their severity, and the evaluators' professional judgments of relationships between the adverse effects and the drugs were documented.
Interventions
DRUGA Natural Remedy for Rheumatoid Arthritis vs. Common Drugs
The comparisons of the efficacy and safety of the following treatments for rheumatoid arthritis: paeoniflorin (PAE) + Cervus and Cucumis polypeptide injection (CCPI), methotrexate (MTX) + leflunomide (LEF), and MTX + LEF + CCPI.
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The relief of rheumatoid arthritis symptoms and the improvement of functions assessed by the American College of Rheumatology (ACR) core set measures. | CCPI: 2 weeks + 2 weeks with 1 week in between. All other drugs: at least 12 months. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The adverse effects associated with the treatments | CCPI: 2 weeks + 2 weeks with 1 week in between. All other drugs: at least 12 months. | 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. |
Countries
China
Outcome results
None listed