"Randomized Comparative Clinical Evaluation Of Shatyadi Churna and Vasadi Kashaya with and without Nitya Virechana in the management of Tamaka Shwasa w.s.r to Chronic Obstructive Pulmonary Disease"
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Changes in the sign & symptoms of Tamak Shwasa w.s.r. to COPD
研究概览
简要总结
NEED OF STUDY: - Ayurveda has advocated Kapha-vata shamak and Vatanulomana chikitsa as line of treatment of Shwasa roga. - Shatyadi churna and Vasadi Kashaya have been selected for the present research work as both the trial drugs are Kapha-vata shamaka in nature and have potential to break or reverse the Samprapti of Shwasa roga. - Acharya Charaka has also indicated the Virechana in the treatment of Tamaka Shwasa. Hence it is planned to see whether addition of Virechana produces any significant difference in the treatment outcome. For the same Snighdha Nitya virechana is selected keeping in view the Alpabala and Pratiloma gati of Vata in the patients of Tamak Shwasa Roga w.s.r. to COPD.
Aims and Objectives 1. To assess the efficacy of Shatyadi Churna andVasadi Kashaya in the management of Tamaka Shwasa w.s.r.to COPD. 2. To assess whether administration of Nitya virechana causes any difference in the outcome of trial drug.
Research Problem:
i. Are Shatyadi churna and Vasadi kashaya effective in the management of Tamak Shwasa roga w.s.r. to COPD?
ii. Does Nitya virechana enhance the efficacy of the trial drugs?
HYPOTHESIS:
Null Hypothesis:
i. Shatyadi churna and Vasadi kashaya are not effective in the management of Shwasa roga w s.r. to COPD?
ii. Nitya virechana does not enhance the efficacy of the trial drugs. Alternate hypothesis:
i. Shatyadi kand Vasadi kashaya are effective in the management of Tamak Shwas roga w.s.r. to COPD?
ii. Nitya virechana enhance the efficacy of the trial drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects willing to participate in this clinical trial.
- •Patients in the age group of 30 to 70 years of either sex.
- •Patients who have FEV1/FVC <0.7 on post bronchodilator spirometry.
排除标准
- •Age below 30 and above 70years of age.
- •Patients suffering from Pulmonary Tuberculosis, Pleural effusion.
- •Patients suffering from Bronchiectasis.
- •Patient suffering from Bronchial Asthma.
- •Patients suffering from congestive heart failure.
- •Patients suffering from Bronchogenic carcinoma or other form of malignancies.
- •Status asthmaticus.
- •Patients with Haemoglobin less than 9 mg/dl.
- •Pregnant and lactating women.
- •Patients suffering from serious systemic disorders like Renal diseases, Ischemic heart Disease, Malignant Hypertension, uncontrolled Diabetes Mellitus.
结局指标
主要结局
Changes in the sign & symptoms of Tamak Shwasa w.s.r. to COPD
时间窗: 30 days
次要结局
- Changes in the pulmonary function test i.e. improvement in the PFT parameters(30 days)