Effect of Curcumin on Lung Inflammation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Change in sputum dysplasia
研究概览
简要总结
Chronic obstructive pulmonary disease (COPD) and lung cancer are leading causes of death and health care use. Diffuse airways inflammation is seen in COPD and is thought to be the reason for deterioration of lung function in COPD. Currently there is no medication available that can modify or reduce this inflammation. Furthermore, from literature review it has been shown that chronic inflammation can result in cancerous changes.
Curcumin is a food additive used for centuries. Several studies showed that curcumin suppress the different inflammatory pathways. Specially, the TNF-alpha and the NF kappa-b are down regulated by this substance. This study was designed to evaluate effect of combination of curcumin+Bioprine on sputum cytology in patients with COPD. This is double-blind randomized pilot study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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
- •Age equal or more than 45 with moderate COPD: FEV1/FVC ratio less than 70 percent; post bronchodilator FEV1 less than 50 percent
- •20 pack year cigarette smoking
- •Stable clinical course (symptoms/ medications) for 8 weeks
- •Fixed address/Not planning to leave
- •Being able to perform spirometry
- •Able to understand and consent
排除标准
- •Other chronic respiratory diseases such as asthma, interstitial fibrosis, sarcoidosis
- •Heart failure NYH III & IV; symptomatic liver or renal failure
- •Dementia or other neurocognitive deficit preventing completion of symptom diary
- •Use of inhaled or systemic corticosteroids within 8 weeks of enrollment in the study
研究组 & 干预措施
Curcumin+bioprine
The study involves active arm of Curcumin+Bioprine
干预措施: Curcumin+Bioprine (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in sputum dysplasia
时间窗: 3 months
We evaluated presence of moderate or worse dysplasia at baseline and each subsequent visits. The primary endpoint of this study is change in sputum cytological abnormality (moderate or worse dysplasia). The change will be comparison of 3-month follow up compared to baseline.
次要结局
- Number of subjects with adverse events in each arm of the study.(3 months)
研究者
Amir Sharafkhaneh
Associate Professor of Medicine
Baylor College of Medicine