A Phase III, Open-Label, Two-Arm, Multi-Center, Comparative Studyto Evaluate the Safety and Efficacy of Amastha Awaleha in SubjectsWith Bronchial Asthma
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- 2. Symptom Reduction:
研究概览
简要总结
Background: Bronchial asthma is a chronic inflammatory disease of the airways, characterized by bronchoconstriction, inflammation, and mucus hypersecretion. This condition leads to symptoms such as wheezing, coughing, chest tightness, and breathlessness, affecting the quality of life of individuals worldwide. In India, asthma remains a common chronic condition, significantly contributing to the national disease burden. Conventional treatments, including bronchodilators and corticosteroids, target asthma symptoms and inflammation but can lead to long-term side effects, prompting interest in complementary and alternative therapies.
Amastha Awaleha is a proprietary Ayurvedic formulation developed by Maheshwari Pharmaceuticals, containing over 30 standardized herbal ingredients. These ingredients, such as Vasa (Adhatoda vasica), Kantakari (Solanum xanthocarpum), and Yashti Madhu (Glycyrrhiza glabra), are known for their bronchodilatory, anti-inflammatory, and immune-enhancing properties. Given the limitations of long-term conventional therapies, Amastha Awaleha may offer an integrative approach to asthma management.
Brief Summary: This Phase III open-label, multi-center clinical trial aims to evaluate the safety and efficacy of Amastha Awaleha as an adjunct to Standard of Care (SOC) in subjects with mild to moderate bronchial asthma. The study will enroll approximately 100 subjects aged 18–60 years and assess whether the addition of Amastha Awaleha to conventional therapy can improve lung function, reduce asthma symptoms, and enhance quality of life over a 90-day period. The study hypothesizes that Amastha Awaleha, when combined with SOC, will lead to superior outcomes compared to SOC alone.
Purpose of the Study: The purpose of this study is to evaluate the efficacy and safety of Amastha Awaleha, a proprietary Ayurvedic formulation, when used as an adjunct to Standard of Care (SOC) in subjects with mild to moderate bronchial asthma. The study aims to determine whether the addition of Amastha Awaleha can improve lung function, reduce asthma symptoms, and enhance overall quality of life compared to SOC alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Open Label
入排标准
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
2. Symptom Reduction:
时间窗: Day 0, 30, 60, 90
1. Lung Function Improvement:
时间窗: Day 0, 30, 60, 90
Change in spirometry parameters, specifically Forced Expiratory Volume in 1 second (FEV1) and Forced Vital Capacity (FVC), from baseline to Day 90. A clinically meaningful improvement is defined as an increase of at least 12% and 200 mL in FEV1 from baseline.
时间窗: Day 0, 30, 60, 90
3. Rescue Inhaler Usage:
时间窗: Day 0, 30, 60, 90
Change in the frequency and severity of asthma-related symptoms (e.g., cough, wheezing, chest tightness, and breathlessness) as recorded in subject diaries and assessed by clinician evaluations from baseline to Day 90.
时间窗: Day 0, 30, 60, 90
Reduction in the frequency of rescue inhaler use over the 90-day treatment period,
时间窗: Day 0, 30, 60, 90
indicating improved symptom management.
时间窗: Day 0, 30, 60, 90
次要结局
- 1. Asthma Control:(Change in Asthma Control Questionnaire (ACQ) scores from baseline to Day 90. A decrease of 0.5 or more is considered the minimal clinically important difference.)