An open labelled randomized active controlled evaluation of effect Of Kanakasava nebulizer solution in chronic obstructive pulmonary disease(COPD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Effect on COPD on the basis of FEV1( through spirometry)
研究概览
简要总结
Chronic obstructive pulmonary disease (COPD) is a common progressive disease that is characterized by persistent respiratory symptoms and airflow limitation that is due to airway and/or alveoli abnormalities usually caused by exposure to noxious particles or gases and influenced by host factors including abnormal lung development.
According to Ayurveda, respiratory diseases can be corelated with Pranavaha strotas vikara where cough, breathing difficulties, disturbed respiratory pattern etc. are the main clinical features. Though it is impossible to correlate COPD with any single disease of Pranavaha stroto dushti, but advanced conditions of diseases such as Kasa and Shwasa may result in the conditions which resembles with COPD.
Kanakasava is a potent anti-asthmatic polyherbal formulation mentioned in Bhaishajya Ratnavali in Hikka/Shwasa Rogadhikara. Kanakasava aqueous solution will be made through simple distillation method of drug extraction. This solution will be administered with the help of nebulizer - a delivery device used to administer medication in the form of a mist inhaled directly in to the lungs and its effectiveness in the form of nebulizer solution will be seen in the management of COPD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Patients between age group 18 to 60 years (both years inclusive) of either gender.
- •2 Patients diagnosed with Mild to Moderate COPD as per GOLD Guidelines
- •3 Patients with symptom of Shwaskashta (Dyspnea) even while resting.
- •4 Willing and able to give written informed consent.
排除标准
- •1 Pregnant or Lactating women 2 History of any chronic respiratory disease other than COPD 3 Patients with known case of Systemic Diseases like Uncontrolled Diabetes and Hypertension.
- •4 Severe cases of COPD as per GOLD guidelines
- •5 History of upper or lower respiratory tract infection, within the previous 30 days.
- •6 History of lung resection of more than one full lobe.
- •7 Have a known sensitivity to formoterol, ipratropium, salbutamol.
- •8 Immunocompromised status such as HIV.
结局指标
主要结局
Effect on COPD on the basis of FEV1( through spirometry)
时间窗: Assessment at baseline(0 hour) and at the end of 24 hours | Assessment at baseline(0 hour), 6 hour, 18 hour and the end of 24 hours
Effect on COPD on the basis of Peak flow meter
时间窗: Assessment at baseline(0 hour) and at the end of 24 hours | Assessment at baseline(0 hour), 6 hour, 18 hour and the end of 24 hours
次要结局
- Effect on COPD on the basis of CAT Score(Effect on COPD on the basis of symptom of Shwasakashta(dyspnea))