Effects of Quercetin on the Oxidative Stress and Inflammatory Markers in COPD Phase II
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Club cell protein 16 (CC16) pg/ml
研究概览
简要总结
This study determines whether quercetin supplementation reduces the inflammation and oxidative stress markers in patients with chronic obstructive pulmonary disease. It is small study with 8 subjects receiving quercetin 1000 mg/day, 8 patients receiving 500 mg/day and 4 subjects receive placebo.
详细描述
Chronic obstructive pulmonary disease (COPD) is a progressive lung disorder and affects millions of people globally. Although the exact mechanisms of pathogenesis of this disease are not well-understood, the general consensus is that oxidative stress and inflammation induced by exposure to cigarette smoke or other environmental or occupational hazards are responsible for development of COPD. Therefore, therapies aimed at decreasing oxidative stress and inflammation constitutes an important component of treating COPD.
The current pharmacological therapies may provide temporary symptom relief, reduce acute exacerbations and hospitalizations, but are associated with side effects. Therefore complementary method of treatment with potentially fewer side effects and relatively well-tolerated provide promising alternative. One such compound is quercetin, which is plant polyphenol and is present in variety of foods that we consume. Quercetin has potent antioxidant and anti-inflammatory properties and reduces oxidative stress and inflammation in a preclinical model of COPD. Quercetin exerts it antioxidant properties not only by neutralizing free radical species, but also by enhancing the expression of antioxidant enzymes. Similarly, quercetin inhibits various protein and lipid kinases by competing for adenosine triphosphate (ATP) binding sites thus reducing the inflammatory pathways.
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)
盲法说明
Randomization codes will be generated by a study statistician at the beginning of the study and is provided to research pharmacist who will be dispensing the study drugs. The study drug bottles will be numbered with no information about the study drug. The randomization codes will not be revealed until all the data is collected and analyzed. Both placebo and quercetin will be similarly packaged and will have similar color, taste and texture.
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
- •Subjects with COPD, 40 - 80 yrs of age
- •Post-bronchodilator forced expiratory volume (FEV)1/forced vital capacity (FVC) ratio 0.7, FEV1% predicted between 40 to 70
- •Both active and ex-smokers with at least 10 pack-years history of smoking
- •COPD patients taking H2 antagonists, loperamide or loratadine and willing to stop during the study period
排除标准
- •Known allergy/sensitivity to quercetin
- •Subjects with primary current diagnosis of asthma
- •Upper respiratory tract infection within two weeks of the screening visit
- •Acute bacterial infection requiring antibiotics within two weeks of screening
- •Emergency treatment or hospitalization within one month of screening for any reasons
- •Unwillingness to stop flavonoid supplementation
- •Dietary intake exceeding or averaging 150 mg quercetin daily as assessed by Bioflavonoid Food and Supplement Screener
- •Daily warfarin or cyclosporine (Neoral, Sandimmune)
- •Subjects taking H2 antagonists (cimetidine, ranitidine), loperamide (Imodium) or loratadine and not willing to stop during study period
- •Lung cancer history or undergoing chemo- or radiation therapy
- •Inflammatory bowel disease
- •Women of child-bearing age and unwilling to take pregnancy test
- •Child-bearing age, who are unwilling to use adequate contraception or abstain during the course of the study.
- •Pregnant or lactating mothers
研究组 & 干预措施
Quercetin 1000 mg/day
Quercetin 1000 mg/day Quercetin is provided as caplet and each caplet will have 500 mg of quercetin Quercetin will be administered orally twice daily, one half dose (1 caplet) in the morning after breakfast and one half dose (1 caplet) in the evening after dinner for six months.
干预措施: Quercetin 1000 mg (Drug)
Quercetin 500mg/day
Quercetin 500 mg/day Quercetin is provided as caplet and each caplet will have 500 mg of quercetin Quercetin will be administered orally once daily, (1 caplet) in the morning after breakfast and matching placebo in the evening after dinner for six months.
The placebo is added to match the number of caplets with 1000 mg/day arm
干预措施: Quercetin 500 MG (Drug)
Placebo
Placebo is also provided as caplets that is similar to quercetin in color, taste and texture and will contain all the stabilizers and the inactive ingredients that is present in the quercetin chews.
Placebo will be administered orally twice daily, one half dose (1caplet) in the morning after breakfast and one half dose (1 caplet) in the evening after dinner for six months.
干预措施: Placebo (Drug)
结局指标
主要结局
Club cell protein 16 (CC16) pg/ml
时间窗: six months
The level of this anti-inflammatory marker in the serum will be measured at the time of recruitment (baseline) and after treatment with placebo, 500mg/day quercetin or 1000 mg/day quercetin
C-reactive protein (CRP), and surfactant protein (SP)-D in serum
时间窗: six months
The levels of these inflammatory markers will be measured at the time of recruitment (baseline) and after treatment with placebo or quercetin 500 g/day or 1000 mg/day in all the patients and
次要结局
- Quercetin(six months)
研究者
Umadevi Sajjan
Associate Professor
Temple University