A Randomized Controlled Open Label Clinical Study to Evaluate the Efficacy of Vyaghryadi Kashayam and Bharangi-Shunthi Churna in the Management of Shwasa Roga with special reference to Chronic Obstructive Pulmonary Disease COPD
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
The study is a randomized clinical trial planned in the post graduate department of kayachikitsa at paprola ayurvedic college . It aims to assess ayurvedic medicines in patients of shwasa roga which is clinically correlated with chronic obstructive pulmonary disease. The trial will evaluate vyaghryadi kashayam and bharangi shunthi churna which are described in classical ayurvedic texts and are believed to reduce kapha and vata related respiratory problems and improve breathing capacity . 30 patients between 40 to 70 years with stable chronic obstructive airway disease will be selected from outpatient and inpatient department. Eligible patients will be divided into 2 groups . one group will receive the vyaghryadi kashayam 40ml twice a day after meal and bharangi shunthi churna 3gm twice a day with lukewarm water and other group will receive doxofylline 400mg once in a day. Treatment duration will be 30 days with follow up after 15 days . Diagnosis and assessment will be based on clinical features of shwasa roga along with modern parameters like spirometery chest xray oxygen saturation and six minute walk test. improvement will be measured using symptoms scoring . Result will be analyzed statistically to understand the effect and safety of trial drugs. The aim is to generate scientific evidence regarding the usefulness of vyaghryadi kashyam and bharangi shunthi churna in managing shwasa roga.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 40.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Willing to provide consent – Patients who voluntarily agree to participate and provide written informed consent. 2 Patients who fulfill the diagnostic criteria. 3 Patients of age group
- •70 years of either gender. 4 Patients who are in a stable phase of COPD ( not experiencing an acute exacerbation in the past 4 weeks). 5 Oxygen saturation (SPO2) more than or equal to 90 percent patients with adequate oxygenation levels without continuous oxygen therapy. 6 Mild to moderate COPD severity- patients with GOLD stage I to II (FEV1 more than or equal to 50 percent predicted but less than 80 percent).
排除标准
- •Patients not willing to participate in the trial.
- •Patients presenting with complications like advanced Type II respiratory failure, lung collapse, pneumothorax.
- •Patients suffering from other associated major illnesses like malignancy, pulmonary tuberculosis, renal failure, congestive heart failure, ischemic heart disease, severe anemia, myocardial infarction etc.
- •Patients below 40 and above 70 years of age.
- •Pregnant and lactating women.
- •Any other condition which the principal investigator thinks may jeopardize the study.
研究者
Dr Manik Soni
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola (HP)