Efficacy of Dashamoola Rasayana in mild to moderate stable Chronic Obstructive Pulmonary Disease against Conventional Modern Medications - A Comparative Randamised Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- The primary outcome, as mentioned, is often the annual decline in lung function (FEV1), which indicates the progression of airflow obstruction
研究概览
简要总结
This randomized, single blind, multicenter trial aims tocompare the efficacy of Dashmool Rasayan 3 grams, four times daily for 30days with conventional modern medications (inhaled bronchodilators,antimuscarinics, bita adrenergic agonists, and inhaled corticosteroids inpatients with mild to moderate COPD. The primary outcome is the annual declinein lung function FEV1 over one year, indicating the progression of airflowobstruction. Secondary outcomes include the frequency of COPD exacerbations flare-upsrequiring treatment assessed over 45 days, changes in respiratory symptomssuch as shortness of breath, cough, and wheezing evaluated at 30 days, andchanges in depression levels as measured by the Beck Depression Inventory BDI score at 4 weeks. In COPD patients, mean baseline BDI scores typically rangebetween 14 and 20, indicating mild to moderate depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 16.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Subjects of Either Sex, age between 16yr-70yr Informed consult provided Subjects Selection of the patients will done on the basis of three criteria viz.
- •Selection of the patients will done on the basis of three criteria viz.
- •Symptomatological criteria, Radiological and Spirometric criteria (given by GOLD 202431 ).
排除标准
- •Severe COPD31(GOLD stage III and IV).
- •GOLD ABE category E31 patients Patients suffering from major systemic illness necessitating long term drug treatment and patients with clinical evidence of heart failure.
- •Patients suffering from other pulmonary diseases like pneumonia, cystic fibrosis, tuberculosis, lung cancer etc Patient suffering from Diabetes mellitus Patient Suffering from Chronic Kidney Diseases.
结局指标
主要结局
The primary outcome, as mentioned, is often the annual decline in lung function (FEV1), which indicates the progression of airflow obstruction
时间窗: 1 year
次要结局
- Exacerbation Rates:(The frequency of COPD flare-ups, which are periods of worsening symptoms requiring treatment.)
