The Use of a New Food-grade Lecithin Formulation of Highly Standardized Ginger (Zingiber Officinale) and Acmella Oleracea Extracts for the Treatment of Pain and Inflammation in a Group of Subjects With Moderate Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in generic pain (Visual Analogue Scale)
研究概览
简要总结
One-group pretest-posttest quasi-experimental design in which primary outcomes were: a) the evaluation of pain intensity, by a 30-days Visual Analogue Scale (VAS) and b) the assessment of knee function by Western Ontario and McMaster Universities Arthritis Index and by Tegner Lysholm Knee Scoring collected at baseline, at 15 and 30 days after treatment. Secondary outcomes were the evaluation: c) of Health-related quality of life, by the ShortForm36, d) of inflammation by C-reactive protein and Erythrocyte Sedimentation Rate, and e) of body composition by dual-energy X-ray absorptiometry measured at baseline and 30 days after treatment.
详细描述
To evaluate the safety and the efficacy on pain and inflammation of a new food-grade lecithin formulation of standardized extracts of Zingiber officinale and Acmella oleracea.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •established moderate knee OA (classification 1-3 according to Kellgren and Lawrence system for classification of knee OA)
- •Lequesne Index of 6-10; 3) Body Mass Index (BMI) between 22 and 30 kg/m2
- •aged 40-75
- •no drugs for OA, such as nonsteroidal anti-inflammatory drugs (NSAIDs).
排除标准
- •diabetes, metabolic disease, or neoplasia, as well as the patients with disabling diseases that could directly affect muscle weakness (such as neurological diseases, hip fractures, or amputations)
结局指标
主要结局
Change in generic pain (Visual Analogue Scale)
时间窗: 0-15-30 days
Pain intensity measured both at motion and at rest, using the Visual Analogue Scale (VAS). VAS measures a characteristic or attitude ranging across a continuum of values and cannot be directly measured. For example, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. The results are showed with a scale 0-10. 0 means no pain and 10 high pain.
Change in knee functionality (TLKS)
时间窗: 0-15-30 days
Tegner Lysholm Knee function Scoring (TLKS). Each patient completed a self-report questionnaire, TLKS, related to knee symptoms and function. It includes eight items: Limp, Support, Locking, Instability, Pain, Swelling, Stair climbing and Squatting. Each possible response to the items gives an arbitrary score on an increasing scale with a maximum of 100, a higher score representing a higher ability.
Change in knee pain (WOMAC)
时间窗: 0-15-30 days
Assessment of knee pain by WOMAC (Western Ontario and McMaster Universities Arthritis) Index. The WOMAC pain scale consists of five questions that assess pain while walking on a flat surface, going up or down stairs, in bed at night, sitting or lying, and standing upright. The responses are recorded on a five-point Likert scale, with a higher score representing a greater level of pain. This scale is valid and reliable in hip and knee OA populations.
次要结局
- Change Health-related quality of life: ShortForm36(0-30 days)
- Change in inflammatory blood markers (CRP) (mg/dl)(0-30 days)
- Change in Total fat mass (Kg), free fat mass (Kg) and visceral adipose tissue (Kg).(0-30 days)
- Change in inflammatory blood markers (ERS) (mm)(0-30 days)