KCT0002368已完成未知
The study of clinical efficacy and safety of traditional medicine, Gumiganghwal-tang in knee osteoarthritis
Soon Chun Hyang University Hospital Cheonan0 个研究点目标入组 161 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 161
研究概览
简要总结
A total of 128 patients were enrolled (91.4% female; mean age, 58.7 ± 8.1 years). At baseline, pain visual analogue score (VAS) was 67.2 ± 1.4, 71.3 ± 1.6 (treatment and placebo group, respectively, p=0.84) and total WOMAC score was 55.2 ± 1.6, 55.6 ± 1.5 (p = 0.84). After 6-weeks, the pain VAS was 43.0 ± 2.5, 61.6 ± 2.5 (treatment and placebo group, respectively, p < 0.01) and the total WOMAC score was 34.1 ± 2.4, 46.9 ± 1.8 (p < 0.01). No patients withdrew because of treatment emergent adverse events. Expected adverse events including dyspepsia, liver function abnormality, and lower extremity edema were comparable between both groups.
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 40(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •Participants who met the following inclusion criteria were recruited to the trial: age 40 years or older, diagnosis of clinical symptomatic knee osteoarthritis defined using the American College of Rheumatology (ACR) criteria for at least 3 months before screening, documented radiographic changes indicating osteoarthritis of the knee (Kellgren-Lawrence grade greater than or equal to 2 at the time of screening), pain in at least one knee with a visual analogue scale pain score of = 50 mm and < 80 mm ( 1-100 mm scale), pain requiring analgesia or nonsteroidal anti-inflammatory drugs (NSAIDs) /selective COX-2 inhibitors at least 5 days or more a week in the last month, not pregnant or lactating, use of effective contraception if participant is a woman of childbearing age, and a signed consent statement.
排除标准
- •Patients with congestive heart failure, uncontrolled hypertension, a history of stroke, renal artery stenosis, ischemic heart disease or renal failure, hypersensitivity or intolerance to nonsteroidal anti-inflammatory drugs (NSAIDs)/aspirin/selective cox-2 inhibitor, hemostatic dysfunction including concurrent warfarin treatment, inability to provide informed consent, who were pregnant or lactating were excluded. Patients were also excluded if they had concurrent disease resulting in secondary osteoarthritis such as a fracture, septic arthritis or inflammatory arthritis, if they underwent orthopedic surgery within the 6 months prior to screening, or if they planned to have a surgical procedure during the study period.
研究者
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