A Clinical Study of a Natural Remedy for Rheumatoid Arthritis vs. Commonly Used Conventional Medications
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,748
- 试验地点
- 2
- 主要终点
- The relief of rheumatoid arthritis symptoms and the improvement of functions assessed by the American College of Rheumatology (ACR) core set measures.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •poor compliance
- •severe medical conditions
- •abnormalities in liver, or kidney function, or in haematological parameters,
- •pregnancy or breast feeding
研究组 & 干预措施
Paeoniflorin + Polypeptides (PAE + CCPI)
Paeoniflorin (PAE), the extract from peony (Paeonia lactiflora), is an active ingredient with anti-inflammation properties. Polypeptides (3,000 - 10,000 dalton) in Cervus & Cucumis polypeptide injection (CCPI), the extract from Sika deer (Cervus nippon Temmick) bones and muskmelon (Cucumis melo L) seeds, are the active ingredients with bone healing, pain relieving, and anti-inflammation properties. PAE was administrated orally 600 mg twice a day for at least 12 months. CCPI was administered intravenously 8~12 mL daily with 250 mL 5% dextrose injection solution or 0.9% NaCl IV solution for 2 weeks, discontinued 1 week, and restarted for another 2 weeks.
干预措施: A Natural Remedy for Rheumatoid Arthritis vs. Common Drugs (Drug)
Methotrexate (MTX) + Leflunomide (LEF)
DMARDs (methotrexate: MTX, leflunomide: LEF) were taken orally for at least 12 months. MTX dose: 7.5 mg ~ 10mg / week, LEF dose: 10 mg ~ 20mg daily.
干预措施: A Natural Remedy for Rheumatoid Arthritis vs. Common Drugs (Drug)
MTX + LEF + CCPI
The DMARDs and CCPI were administrated as in the above two groups.
干预措施: A Natural Remedy for Rheumatoid Arthritis vs. Common Drugs (Drug)
结局指标
主要结局
The relief of rheumatoid arthritis symptoms and the improvement of functions assessed by the American College of Rheumatology (ACR) core set measures.
时间窗: 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.
次要结局
- The adverse effects associated with the treatments(CCPI: 2 weeks + 2 weeks with 1 week in between. All other drugs: at least 12 months.)