A single arm clinical study to evaluate the efficacy of Pankajakasthuri Breathe Eazy excel powder in managing various respiratory Disorders
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Any marked change in safety parameters
研究概览
简要总结
Respiratory disorders impose a significant burden on individuals’ health and well-being globally. Herbal formulations have gained attention for their potential in managing such conditions. This single-arm clinical study aimed to evaluate the efficacy of Pankajakasthuri Breathe Eazy Excel Powder in managing various respiratory disorders. A total of 200 participants diagnosed with respiratory disorders, including asthma, chronic bronchitis, and allergic rhinitis, were enrolled in the study. Participants were administered Pankajakasthuri Breathe Eazy Excel Powder according to the recommended dosage for a duration of 6 months. Primary outcomes included improvements in respiratory symptoms, lung function parameters, and quality of life scores, assessed through standardized tools. Secondary outcomes comprised safety profiles and adverse events associated with the intervention. Statistical analyses were conducted to assess the significance of changes observed pre- and post-intervention. The results demonstrated statistically significant improvements in respiratory symptoms, lung function parameters, and quality of life scores following the administration of Pankajakasthuri Breathe Eazy Excel Powder. Moreover, the intervention exhibited a favorable safety profile with minimal adverse events reported. These findings suggest that Pankajakasthuri Breathe Eazy Excel Powder holds promise as an effective and safe adjunctive therapy for managing various respiratory disorders. Further randomized controlled trials with larger sample sizes are warranted to corroborate these findings and establish the clinical utility of this herbal formulation.
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 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Age 18 Years and above Patients willing to take Breathe Eazy Excel Powder in a dose of 1 Tea spoon twice daily after food continuously for a minimum period of 3 months.
- •Subjects willing to enroll in study by signing Informed consent.
- •Subjects presenting with Allergic bronchitis, Allergic rhinitis, COPD, Sinusitis, Eosinophilia and other Respiratory tract infections.
排除标准
- •1 Patients allergic to the any of the ingredients of Breathe Eazy Excel Powder.
- •Pregnant and Lactating mother.
结局指标
主要结局
Any marked change in safety parameters
时间窗: 0th-baseline1st-first time blood investigations | and 2nd-Blood investigations the end of the | study.
measured during the administration of the
时间窗: 0th-baseline1st-first time blood investigations | and 2nd-Blood investigations the end of the | study.
product.
时间窗: 0th-baseline1st-first time blood investigations | and 2nd-Blood investigations the end of the | study.
• Reporting the effectiveness of this product in
时间窗: 0th-baseline1st-first time blood investigations | and 2nd-Blood investigations the end of the | study.
the management of Allergic bronchitis, Allergic
时间窗: 0th-baseline1st-first time blood investigations | and 2nd-Blood investigations the end of the | study.
rhinitis, COPD, Sinusitis, Eosinophilia and other
时间窗: 0th-baseline1st-first time blood investigations | and 2nd-Blood investigations the end of the | study.
Respiratory tract infections and associated
时间窗: 0th-baseline1st-first time blood investigations | and 2nd-Blood investigations the end of the | study.
complaints.
时间窗: 0th-baseline1st-first time blood investigations | and 2nd-Blood investigations the end of the | study.
次要结局
- Additional therapeutic advantages of the product(0th-baseline1st-first time blood investigations and)
研究者
DrJHareendran Nair
Pankajakasthuri Herbal research Foundation
