An Open-Label, Two-Arm, Multi-Centered Clinical Study To Evaluate The Safety And Efficacy Of Ethniq Lung Detox Bars And Paste In Subjects For Lung Health.
概览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Ethniq Ayush Exports LLP
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Improvement in Lung Function (Relative to Baseline):
概览
简要总结
BACKGROUND AND INTRODUCTION
Respiratory health is increasingly affected by pollution, smoking, and occupational exposure, leading to conditions like chronic cough, bronchitis, and mild asthma. While herbal remedies like Vasa, Mulethi, and Pippali show potential benefits, clinical evidence is limited.
This study evaluates the safety and efficacy of Ethniq Lung Detox Bars and Paste in improving lung health. The formulations contain:
- Vasa (Adhatodavasica): Bronchodilator and anti-inflammatory.
- Mulethi (Glycyrrhizaglabra): Expectorant and respiratory soother.
- Pippali (Piper longum): Reduces airway resistance.
Key outcomes include reduced cough, improved bronchial comfort, better asthma symptom control, and enhanced lung detoxification.
PURPOSE OF THE STUDY
This study aims to evaluate the safety and efficacy of Ethniq Lung Detox Bars and Paste in improving lung health and managing mild to moderate respiratory conditions, including chronic cough, bronchitis, and mild asthma. The study will assess their impact on cough severity, bronchial comfort, lung function, and detoxification to provide clinical evidence supporting their use.
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
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age between 18 to 65 years
- •Respiratory symptoms include participants presenting with mild to moderate symptoms such as coughing, wheezing, or shortness of breath.
- •Participants with mild to moderate asthma should have an ACT score of 16 or higher and an FEV1 of 60 percent or higher to ensure the inclusion of controlled asthma cases.
- •Eligible participants include those with chronic cough, bronchitis, mild asthma, or those seeking lung detoxification support.
- •Participants must be willing to provide informed consent and adhere to the study protocol.
排除标准
- •Diagnosed with severe chronic respiratory diseases such as COPD or severe asthma requiring urgent medical care or long-term medication.
- •Respiratory conditions that required hospitalization within the past six months.
- •ACT score below 16, GOLD Stage 3 or 4 for COPD, or dependency on systemic steroids or oxygen therapy.
- •Severe cardiovascular diseases, including a heart attack or stroke within the past year.
- •Known allergy or hypersensitivity to any ingredient in the Lung Detox Bars or Paste.
- •Pregnant or breastfeeding women.
- •Use of investigational drugs or devices within 30 days prior to the study.
- •Severe comorbidities that may interfere with study outcomes or participant safety.
结局指标
主要结局
Improvement in Lung Function (Relative to Baseline):
时间窗: Day 0, Day 30, Day 45, Day 60 and Day 90
PFT Parameters: Increase in lung volume, vital capacity, and tidal volume.Spirometry Metrics: Improvement in FEV1, FVC, and FEV1/FVC ratio.
时间窗: Day 0, Day 30, Day 45, Day 60 and Day 90
次要结局
- 1. Chronic Cough: Reduction in severity and frequency, as measured by the Leicester Cough Questionnaire and Visual Analog Scale (VAS).(2. Bronchitis: Improvement in bronchial comfort and reduction in sputum production.)
研究者
Ms Arpita Malgi
Samahitha Research Solutions