A Nutritional Supplement Epigenome Antivir Combined With Acupuncture for the Treatment of Osteoarthritis Who Are Overweight or Obese
试验速览
- 阶段
- 不适用
- 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 a supplement Epigenome-Antivir (extracts of glycyrrhiza roots, hippophae rhamnoides leaves, curcumin, green tea, and vitamin C) combined with acupuncture in patients with knee osteoarthritis (OA) and metabolic syndrome.
详细描述
Epigenome-Antivir components have long been used in traditional medicine and have been shown to exert anti-inflammatory properties both in vitro and in vivo. It has also been shown that acupuncture can provide a moderate analgesic effect in osteoarthritis. It is anticipated that the combination of Epigenome-Antivir and acupuncture will reduce pain, inflammatory and metabolic markers in patients with OA and metabolic syndrome.
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 80 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
- •BMI of 25 or more
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
Epigenorm Antivir and acupuncture arm
Epigenorm Antivir is a dietary supplement containing extracts of glycyrrhiza roots, hippophae rhamnoides leaves, curcumin, green tea, and vitamin C. Acupuncture involves inserting needles at certain points of the body.
干预措施: Epigenorm Antivir (Dietary Supplement)
Epigenorm Antivir and acupuncture arm
Epigenorm Antivir is a dietary supplement containing extracts of glycyrrhiza roots, hippophae rhamnoides leaves, curcumin, green tea, and vitamin C. Acupuncture involves inserting needles at certain points of the body.
干预措施: Acupuncture (Procedure)
结局指标
主要结局
Change From Baseline in Visual Analogue Scale for Pain
时间窗: Baseline, 4 weeks, 8 weeks, 12 weeks
The Visual Analogue Scale for Pain varies from 0 to 10 cm. Higher values represent worse outcomes.
次要结局
- Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Symptoms(Baseline, 4 weeks, 8 weeks, 12 weeks)
- Quality of life with the The Short Form (36) Health Survey score(Baseline, 4 weeks, 8 weeks, 12 weeks)
- Changes in serum levels of aggrecan(Baseline, 8 weeks)
- Intermittent and Constant Osteoarthritis Pain self-report questionnaire(Baseline, 4 weeks, 8 weeks, 12 weeks)
- Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Activities of daily living (ADL)(Baseline, 4 weeks, 8 weeks, 12 weeks)
- Changes in serum levels of C-reactive protein(Baseline, 8 weeks)
- Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Pain(Baseline, 4 weeks, 8 weeks, 12 weeks)
- Changes in serum levels of antibodies to collagen type II(Baseline, 8 weeks)
- Changes in histamine levels(Baseline, 8 weeks)
- Changes in inflammation biomarkers(Baseline, 8 weeks)
- Changes in lipid biomarkers(Baseline, 8 weeks)
- Changes in depression scores measured with Patient Health Questionnaire-9 (PHQ9P)(Baseline, 4 weeks, 8 weeks, 12 weeks)
研究者
Ivan Shirinsky, MD, PhD
Principal Investigator
Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology