CTRI/2019/09/021105尚未招募2 期
To Determine the Effects of Docosahexaenoic Acid (DHA) Supplementation Along With Inhaled Budesonide with or without Long- acting Beta-agonist (LABA): A Clinical Study in Steroid Resistance/Insensitive Asthma Patients.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •â??Steroid refractory asthmaâ?? should be diagnosed as per American Thoracic Society workshop that was conducted in year 2000 (for the convenience the contents of Table 1 of published report â??Proceedings of the ATS workshop on refractory asthma: current understanding, recommendations, and unanswered questions. American Thoracic Society. [No authors listed] Am J Respir Crit Care Med. 2000 Dec;162(6):2341-51.â?? has been given here).
- •The workshop had devised two major and seven minor criteria. According to the workshop, a patient can be defined as steroid refractory if that patient has one or both major and minimum two minor criteria.
- •Major criteria: To attain a control to a level of mild-moderate persistent asthma patient, will be based on:
- •1. Treatment with continuous or near continuous ( >50% of year) oral corticosteroids
- •2. Requirement for treatment with high-dose inhaled corticosteroids
- •Minor Criteria:
- •1. Requirement for daily treatment with a controller medication in addition to inhaled corticosteroids, e.g., long-acting β-agonist, theophylline, or leukotriene antagonist
- •2. Asthma symptoms requiring short-acting β-agonist use on a daily or near daily basis
- •3. Persistent airway obstruction (FEV1, 80% predicted; diurnal PEF variability >20%)
- •4. One or more urgent care visits for asthma per year
- •5. Three or more oral steroid bursts per year
- •6. Prompt deterioration with <25% reduction in oral or inhaled corticosteroid dose
- •7. Near fatal asthma event in the past.
排除标准
- •1. Pregnancy or lactation
- •2. Patients with liver disease
- •3. Patients with coronary artery disease or any other serious heart diseases like arrhythmias, heart attacks, strokes and heart failures
- •4. Alcoholic intake in the last year before recruitment.
- •5. Life-threatening asthmatic condition in the last one year before the recruitment.
- •7. Hospitalized for asthmatic attack/exacerbation or severe lung infection in the last one month before recruitment.
- •8. Use of DHA capsules or other nutritional supplements that contains DHA at the time of recruitment.
- •9. Allergic to fish foods/oils
- •10. Active smokers with at least 10 pack years in case of asthma
- •11. Known case of HIV and other lung diseases like lung cancer, tuberculosis, Broncho pulmonary aspergillosis, cystic fibrosis, and bronchiectasis.
研究者
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