Analgesic, Antiinflammatory and Metabolic Effects of Comarum Palustre in Patients With Osteoarthritis and Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change From Baseline in Visual Analogue Scale for Pain
研究概览
简要总结
The study evaluates analgesic, antiinflammatory and metabolic effects of Comarum palustre in patients with knee osteoarthritis (OA) and diabetes mellitus. Patients with osteoarthritis will receive Comarum palustre together with conventional treatment of osteoarthritis and diabetes.
详细描述
Comarum palustre have been shown to exert analgesic properties in patients with knee osteoarthritis not responding to diclofenac. In animal models comarum palustre showed anti-inflammatory, immunomodulatory, analgesic, antioxidant, antihistamine, and membrane-stabilizing effects. Thus, pleiotropic properties of Comarum Palustre may provide a rationale for this use in patients having both osteoarthritis and diabetes mellitus. In this group of patients Comarum Palustre may not only relieve OA-related pain but reduce systemic inflammation, decrease progression of atherosclerosis and diabetes complications.
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
- •osteoarthritis of the knee fulfilling American College of Rheumatology (ACR) criteria
- •diagnosis of type 2 diabetes mellitus
排除标准
- •use of NSAIDs one month prior to study entry (paracetamol is allowed)
- •pregnancy and lactation
- •increased sensitivity to the study drug
- •clinically significant renal function impairment
- •use of antidepressants
- •diagnosis of bipolar disorder
- •use of symptomatic slow acting drugs of OA (SYSADOA) one month prior to study entry
- •any condition which may lead to difficulties to participation in the study from the viewpoint of Investigator
研究组 & 干预措施
Comarum Palustre
Patients taking Comarum Palustre together with conventional treatment for osteoarthritis
干预措施: Comarum Palustre (Drug)
结局指标
主要结局
Change From Baseline in Visual Analogue Scale for Pain
时间窗: Baseline, 4 weeks
The Visual Analogue Scale for Pain varies from 0 to 10 cm. Higher values represent worse outcomes.
次要结局
- Changes in neopterin levels(Baseline, 4 weeks)
- Quality of life with the The Short Form (36) Health Survey score(Baseline, 4 weeks)
- Changes in serum levels of aggrecan(Baseline, 4 weeks)
- Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Pain(Baseline, 4 weeks)
- Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Activities of daily living (ADL)(Baseline, 4 weeks)
- Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Symptoms(Baseline, 4 weeks)
- Intermittent and Constant Osteoarthritis Pain self-report questionnaire(Baseline, 4 weeks)
- Changes in serum levels of antibodies to collagen type II(Baseline, 4 weeks)
- Changes in serum levels of C-reactive protein(Baseline, 4 weeks)
- Changes in histamine levels(Baseline, 4 weeks)
- Changes in inflammation biomarkers(Baseline, 4 weeks)
- changes in diabetes control(Baseline, 4 weeks)
- Changes in depression scores measured with Patient Health Questionnaire-9 (PHQ9P)(Baseline, 4 weeks)
- Changes in lipid biomarkers(Baseline, 4 weeks)
- Patient global assessment of osteoarthritis(Baseline, 4 weeks)
研究者
Ivan Shirinsky, MD, PhD
Principal Investigator
Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology