An Open label, Single arm, Interventional trial to study the Efficacy and Safety of Shwasakuthara rasa and Kasahara kashaya in Tamaka Shwasa W.S.R. to Bronchial Asthma.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in Asthma control questionnaire (ACQ) score from baseline value at the end of 4th week.
研究概览
简要总结
Ayurvedic literature has vast references of formulations indicated for clinical conditions similar to asthma. On the basis of those references, “Shwasakuthara Rasa†and “Kasahara Kashaya†have been selected for the present clinical study.
Shwasakuthara Rasa is a herbo-mineral formulation mentioned for the management of Shwasa whereas Kasahara Kashaya is described by Acharya Charaka as Mahakashaya having ten herbal ingredients for the treatment of cough.
Previous studies have reported beneficial effects of Shwasakuthara Rasa in management of asthma. Present trial will focus on assessment of combined efficacy and safety of Shwasakuthara Rasa and Kasahara Kashaya in asthma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
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 of either sex in age group of 18-60 years.
- •patients with intermittent, mild- persistent and moderate persistent asthma according to GINA classification.
- •3.Patients presenting with symptoms of allergic rhinitis and having associated asthma symptoms as per GINA classification.
- •4.Patients who have not received any AYUSH intervention in last 15 days for related symptoms.
排除标准
- •1.Patients having acute exacerbation of asthma at the time of recruitment.
- •2.Patients having severe persistent asthma as per GINA classification.
- •3.Patient having any acute respiratory infection or have received any modern medication for such illness in last 15 days.
- •4.Patients having past or recent diagnosis/treatment of tuberculosis, pneumonia, COPD, bronchiectasis.
- •5.Patient having history of any hypersensitivity to any of the ingredient/s of the trial drugs.
- •6.Patients having history or diagnosis of any type of malignancy.
- •7.Patients on regular anti allergic medications.
- •8.Patients receiving aspirin, oral corticosteroids or are on regular inhaled corticosteroids.
- •9.Patients on immunotherapy for allergy.
- •10.Patients with Hemoglobin less than 9.0 g/dl.
- •11.Patients having concomitant systemic illness like uncontrolled hypertension, poorly controlled diabetes, renal failure, and severe acute or chronic liver disease.
- •12.Pregnant and lactating mothers.
结局指标
主要结局
Changes in Asthma control questionnaire (ACQ) score from baseline value at the end of 4th week.
时间窗: 0,2 week,4 week
次要结局
- Changes in Peak expiratory flow rate (PEFR) and FEV1 and FVC; in Fractional exhaled Nitric Oxide (FeNO) value; in Absolute Eosinophil count, IgE value from baseline value at the end of 4th weeks.(Changes in Asthma Quality of Life (AQLQ) score from baseline value at the end of 4th week.)
研究者
Dr Deval Kevadiya
National Institute of Ayurveda, Deemed to be University, Jaipur