跳至主要内容
临床试验/CTRI/2025/04/084547
CTRI/2025/04/084547尚未招募2/3 期

An Open Labelled Active-controlled Randomized Clinical Study To Evaluate The Efficacy Of Ashwagandhadi Churna In Tamak Shwasa With Special Reference to Bronchial Asthma

Parul Institute of Ayurved1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年1月5日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
To assess Immunomodulatory and Bronchodilator effect of Ashwagandhadi Churna in the managemnet of Bronchial Asthma on the basis of spirometry of GINA Guidelines 2024

研究概览

简要总结

Bronchial Asthma is a chronic inflammatory disorder of the airways involving various cells and cellular components. This inflammation causes airway hyper-responsiveness, leading to repeated episodes of wheezing, breathlessness, chest tightness, and coughing, especially during the night or early morning. Over the past few decades, the prevalence of asthma has increased, affecting individuals of all age groups. It is now recognized as a major contributor to global disability. While genetics play a role in the development and progression of asthma, the rapid rise in its prevalence points to the significant influence of environmental factors. A key feature of asthma is airway hyper-reactivity, where the airways respond excessively to harmless triggers. The loss of immune tolerance to inhaled allergens is considered a leading cause of asthma, resulting in an abnormal immune response. In Ayurveda, Bronchial Asthma is correlated with Tamaka Shwasa, a chronic disorder of the pranavaha srotas that disturbs daily activities with symptoms like cough and difficulty in breathing. Tamaka Shwasa is identified as a Swatantra Vyadhi with distinct causes and treatments. Classical texts describe it as a palliative or difficult-to-cure disease, requiring proper management and lifestyle adaptations. Pathologically, Tamaka Shwasa occurs due to an imbalance of Kapha and Vata doshas, often triggered by cold, dry food or seasonal changes, leading to airway obstruction. Ayurvedic formulations like Ashwagandhadi churna help in managing the condition by pacifying Vata and removing Kapha-induced blockages in the airways. Globally, asthma affects around 300 million people, with numbers expected to rise to 400 million by 2025. It is more prevalent in males, with a 2 to 1 male to female ratio. Asthma remains a major health concern, particularly in low and middle income countries, contributing to high treatment costs and productivity losses.

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 65.00 Year(s)(—)
性别
All

入选标准

  • Patients diagnosed with well controlled and partly controlled Bronchial Asthma as per GINA 2024 Guideline of Bronchial Asthma Patients with Prebronchodilator FEV1 of Greater than 60 Percentage of the predicted value Patient willing to sign the informed consent and can participate in the study procedure.

排除标准

  • Pregnant or lactating women Known cases of Diabetes, uncontrolled hypertension, heart disease, secondary severe infections, Pleural effusion, pneumonia and pneumothorax, etc.
  • Uncontrolled Bronchial Asthma as per GINA Guidelines 2024 Severe Bronchial Asthma as per GINA Guidelines 2024 Patients with Prebronchodilator FEV1 Less than 60 Percentage of the predicted value History of upper or lower respiratory tract infection, within the previous 30 days History of lung resection of more than one full lobe Have a known sensitivity to formoterol, ipratropium, and salbutamol etc medicine Immunocompromised status such as HIV, tuberculosis, cancer, etc.

结局指标

主要结局

To assess Immunomodulatory and Bronchodilator effect of Ashwagandhadi Churna in the managemnet of Bronchial Asthma on the basis of spirometry of GINA Guidelines 2024

时间窗: Spirometry-On Screening visit and 60th day

次要结局

  • To assess Immunomodulatory and Bronchodilator effect of Ashwagandhadi Churna in the managemnet of Bronchial Asthma on the basis of IgE,WBC and Asthma Control Quiestionnaire(IgE-On Screening visit and 60th day)

研究者

发起方
Parul Institute of Ayurved
申办方类型
Private medical college

研究点 (1)

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