NCT02333084Unknown2 期
The Influence Of a Natural Anti-Inflammatory Product On Levels Of Inflammatory Markers In Cases With Osteoarthritis Of Knee
Physician Recommended Nutriceuticals1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2014年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Human Inflammation Multi analyte profile (MAP) v1.0 in Synovial fluid and blood
研究概览
简要总结
This is a randomized, placebo controlled study. The first subject is expected to be enrolled in July 2014, and the last subject is expected to complete the study by July 2015. Each subject will be provided with the PRN Joint Comfort Formula, placebo or PRN Flex Omega Benefits® combination depending on randomization (1:1:1 at each site) during the course of the study. Instructions and frequency of use will be determined by the labelling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 and ≤ 90 at the time of informed consent.
- •Subjects with symptomatic moderate arthritis of the knee defined as per
- •Kellgren-Lawrence grade II or III (Appendix B). Subjects with bilateral arthritis of the knee will also be recruited, but only one knee will be enrolled into the study.
- •Ability to walk 50 feet unassisted.
- •Lequesne's Functional Index score greater than 7 points
排除标准
- •Subjects with systemic inflammatory conditions such as inflammatory bowel disease, psoriasis, eczema, and others
- •Subjects with seropositive or sero-negative inflammatory arthritis of the knee such as rheumatoid arthritis or ankylosing spondylitis.
- •Subjects taking hormone replacement therapy
- •Intra-articular corticosteroid injections 3 weeks prior to enrollment.
- •Hypersensitivity to fish oil.
- •Hypersensitivity to non-steroidal anti-inflammatory drugs, abnormal liver of kidney function tests, history of peptic ulceration and upper gastrointestinal hemorrhage, congestive heart failure, Hypertension (BP>140/90), cancer and hyperkalemia.
- •Major abnormal findings on complete blood count, history of coagulopathies, hematological or neurological disorders.
- •High alcohol intake (>2 standard drinks per day). Pregnant, breastfeeding or planning to become pregnant during the study
- •Subjects awaiting surgery on the affected knee within three months.
- •Consumption of any other vitamins/supplements will be allowed, provided the dose is not increased, and same brand is continued with. Also, the regimen should not contain the same active compounds tested in the PRN Joint health formula product.
- •Vitamins/supplements cannot be introduced during a subject's participation in the study.
研究组 & 干预措施
Joint Health Product
Experimental
natural dietary supplement
干预措施: PRN Joint Health Formula (Dietary Supplement)
Placebo
Placebo Comparator
vegetable oil placebo
干预措施: placebo (Dietary Supplement)
Combination with Omega-3
Active Comparator
combination with omega-3 fish oil
干预措施: PRN Flex Omega Benefits® combination (Dietary Supplement)
结局指标
主要结局
Human Inflammation Multi analyte profile (MAP) v1.0 in Synovial fluid and blood
时间窗: 12 weeks
46 different markers of inaflammation will be studies
次要结局
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(12 weeks)
- Pain scores on Visual analog scale(12 weeks)
研究者
研究点 (1)
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