Evaluation of the Crucumin Effects on the Cellular and Humoral Immune Systems in Osteoarthritis Patients; a Randomised Double Blind Placebo Control Clinical Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- IL-17
研究概览
简要总结
In this study, the effects of crucumin on cellular and humoral immune system in patients with osteoarthritis will be investigated. Concentration of CXCL8, April, CX3CL1 and IL-17 will be evaluated with ELISA. TH-1, TH-17, TReg and Ly.B cells count will be measured by Flowcytometry. MicroRNA-720, MicroRNA-155, MicroRNA-16 and MicroRNA-146a gene expression will be measured with Real Time PCR technique.
详细描述
The purpose of this study was to evaluate the effect of the active ingredient of crucumin on the reduction of symptoms of osteoarthritis. Of the 30 patients participating in this study, a blood sample will be taken at the beginning of the study, and then after three months of taking the crucumin. To evaluate the response to treatment, after each person sampling, we will analyze cell count for Th-1, Th-17, TReg and Ly.B by flowcytomtry method. Also we will measure cytokines level of IL-17, CXCL8, CX3CL1 and April by ELISA method. Finally we evaluate the gene expression of MicroRNA-720, MicroRNA-155, MicroRNA-146a and MicroRNA-16 by Real Time PCR technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Osteoarthritis patients who have been diagnosed with a rheumatologist physician based on clinical examinations and laboratory tests
排除标准
- •Affected by any other acute or chronic underlying disease
研究组 & 干预措施
Patients who will recieve crucumin
patients who prescribing crucumin 80 mg daily for three months will be evaluated. A sample will be taken before taking the drug.
干预措施: Crucumin (Drug)
Patients who will receive placebo
Patients who prescribing placebo daily for three months will be evaluated. A sample will be taken before taking the placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
IL-17
时间窗: Baseline
Cytokine level
次要结局
- TH-1(Baseline and three months)
- MicroRNA-720(Baseline and three months)
- MicroRNA-155(Baseline and three months)
- April(Baseline and three months)
- MicroRNA-16(Baseline and three months)
- IL-17(Baseline and three months)
- CXCL8(Baseline and three months)
- CXCL1(Baseline and three months)
- TH-17(Baseline and three months)
- TReg(Baseline and three months)
- MicroRNA-146a(Baseline and three months)
- Ly.B(Baseline and three months)
研究者
Dr. Mojgan Mohammadi
Associate Professor
Mashhad University of Medical Sciences