Efficacy of Vasadi Kwath versus Ashwagandhadi Churna in the management of Tamaka Shwasa w.s.r. Bronchial Asthma: An open label randomised comparative study
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Evaluate the changes in frequency and severity of asthma symptoms as assessed by grading
研究概览
简要总结
The text discusses Tamaka Shwasa, an Ayurvedic disorder akin to Bronchial Asthma, which affects the respiratory system by vitiating the Prana Vayu (life force responsible for respiration). This condition is caused by an imbalance of Kapha and Vata doshas, influenced by factors like environmental pollution, dietary habits, and psychological stress. It is characterized by obstruction in the airways, leading to symptoms such as wheezing and difficulty breathing.
Tamaka Shwasa is considered a chronic, recurrent disorder, with environmental and lifestyle factors increasing its prevalence globally. Ayurveda suggests treatments that focus on clearing the Kapha obstruction in the respiratory system, restoring normal Vayu function, and using herbs with anti-allergic properties. Although there are indigenous Ayurvedic treatments, the need for further clinical studies is emphasized to support their efficacy. The goal is to manage asthma with minimal symptoms, prevent exacerbations, and reduce healthcare costs.
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
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient has asthma with severity ranging from Intermittent asthma to Moderate Persistent asthma, according to the NAEPP 2020 Guidelines.
- •FEV1 more than 60%.
- •Chronicity less than 10 years
- •Patient presenting with features of Tamaka shwasa as in ayurvedic classical textbooks.
排除标准
- •1.Patients on prolonged (more than 6 weeks) medication with corticosteroids, bronchodilators, mast cells stabilizers, antidepressants, anticholinergics, or any other drugs that may have an influence on the outcome of the study.
- •2.Patients who have a past history of Atrial fibrillation, Acute Coronary Syndrome, Myocardial Infraction, stroke or severe Arrhythmia in last 6 months 3.Patient having systemic illness necessitating long term drug treatment like TB, carcinoma, endocrine disorders, concurrent major liver or renal disorders, psychological disorders, neurological disorders like epilepsy, meningitis, stroke etc.
- •4.Patients who have completed participation in any other clinical trial during the past 6 months 5.Patient having pulmonary diseases other than asthma 6.Patient with Diabetes mellitus (FBS more than 126 mg/dl) 7.Patient with poorly controlled Hypertension (Systolic more than 140mm Hg and Diastolic more than 90 mm of Hg) 8.Patient having SPO2 less than 90% 9.Emergency patients requiring O2 inhalation 10.Hypersensitivity to any of the content of the trial drug 11.Pregnant and lactating women 12.Smoker or alcoholic or drug abusers.
结局指标
主要结局
Evaluate the changes in frequency and severity of asthma symptoms as assessed by grading
时间窗: Day 1, 91
of clinical symptoms, Asthma control questionnaire.
时间窗: Day 1, 91
Proportion of participants having 50% relief in the grading of clinical symptoms will be considered as improvement
时间窗: Day 1, 91
次要结局
- Measure changes in pulmonary function parameters such as FEV1, FVC, PEFR, before and(after treatment.)
研究者
Dr Dharnendra Jain
Ayurvedic And Unani Tibbia College And Hospital