Department of Medicine, School of Medicine, Loma Linda University Health, Loma Linda, CA, USA.
Department of Cardiopulmonary Sciences, School of Allied Health Professions, Loma Linda University Health, Loma Linda, CA, USA.
BMC Pulm Med. 2021 Aug 17;21(1):268. doi: 10.1186/s12890-021-01619-y.
Curcumin, a derivative of the spice turmeric, has been adopted by Eastern medicine for centuries as an adjunct to treat several medical conditions (e.g., anorexia and arthritis) because of its well-established anti-inflammatory properties. Studies have shown that the use of curcumin in mice models has led to reduction in several inflammatory markers as well as key inflammatory pathway enzymes. As a result, studies in Western medicine have developed to determine if this recognized benefit can be utilized for patients with inflammatory lung diseases, such as asthma. This study will seek to better understand if curcumin can be used as an adjunctive therapy for improving asthma control of patients with moderate to severe asthma; a finding we hope will allow for a more affordable treatment.
This study will utilize a randomized, placebo controlled, double blinded pilot superiority phase 2 trial at an outpatient pulmonary clinic in Southern California, USA. Subjects will be receiving Curcumin 1500 mg or matching placebo by mouth twice daily for the study period of 12 weeks. Subjects will be randomized to either a placebo or intervention Curcumin. Subjects will have 6 clinic visits: screening visit, a baseline visit, monthly clinic visits (weeks 4, 8, and 12), at weeks 4, 8, and a follow-up clinic visit or phone-call (week 16). Changes in asthma control test scores, number of days missed from school/work, FEV1 (% predicted), FEV1/FVC ratio, FVC (% predicted), blood eosinophil count, blood total IgE, and FeNO levels will be compared by group over time.
The therapeutic effects of curcumin have been studied on a limited basis in asthmatics and has shown mixed results thus far. Our study hopes to further establish the benefits of curcumin, however, there are potential issues that may arise from our study design that we will address within this paper. Moreover, the onset of the COVID-19 pandemic has resulted in safety concerns that have delayed initiation of our study. This study will contribute to existing literature on curcumin's role in reducing lung inflammation as it presents in asthmatics as well as patients suffering from COVID-19.
This study protocol has been approved by the Institutional Review Board at Loma Linda University Health, (NCT04353310). IND# 145101 Registered April 20th, 2020. https://clinicaltrials.gov/ct2/show/NCT04353310 .
姜黄素是香料姜黄的一种衍生物，由于其具有良好的抗炎特性，几个世纪以来，东方医学一直将其作为辅助治疗多种疾病（例如厌食症和关节炎）的药物。研究表明，在小鼠模型中使用姜黄素可降低几种炎症标志物和关键炎症途径的酶。因此，西方医学的研究已经发展到确定这种公认的益处是否可用于患有炎症性肺部疾病（例如哮喘）的患者。这项研究将试图更好地了解姜黄素是否可作为辅助治疗方法来改善中重度哮喘患者的哮喘控制；我们希望这一发现将使治疗更加经济实惠。
这项研究将在美国南加州的一家门诊肺病诊所进行一项随机、安慰剂对照、双盲的 2 期先导性优效性试验。研究期间，受试者将每天口服姜黄素 1500 毫克或匹配的安慰剂两次，为期 12 周。受试者将随机分为安慰剂或干预姜黄素组。受试者将进行 6 次就诊：筛选就诊、基线就诊、每月就诊（第 4、8 和 12 周），以及第 4、8 周和随访就诊或电话就诊（第 16 周）。将通过组间比较随时间变化的哮喘控制测试评分、缺课/旷工天数、FEV1（%预计值）、FEV1/FVC 比值、FVC（%预计值）、血嗜酸性粒细胞计数、血总 IgE 和 FeNO 水平。
姜黄素的治疗效果在哮喘患者中已进行了有限的研究，迄今为止结果喜忧参半。我们的研究希望进一步确定姜黄素的益处，但是，我们的研究设计可能会出现一些潜在问题，我们将在本文中进行讨论。此外，COVID-19 大流行的爆发引起了对安全性的担忧，导致我们的研究推迟开始。本研究将有助于现有的关于姜黄素在降低哮喘患者和 COVID-19 患者肺部炎症中的作用的文献。
本研究方案已获得洛马林达大学健康分校机构审查委员会的批准（NCT04353310）。IND# 145101 于 2020 年 4 月 20 日注册。[临床试验.gov/ct2/show/NCT04353310]。
