CTRI/2022/01/039180已完成2/3 期
A randomized, controlled clinical study to compare efficacy of a polyherbal formulation (GP/PROD/2021/004) versus Standard Allopathic Formulation for relief of acutenonproductive cough and throat irritation
Mr Kamlesh Thummar2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年1月16日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- 1. Changes in day and night frequencies of cough from baseline to end of treatment period on a 6-point scale
研究概览
简要总结
The clinical study is planned to evaluate clinical effectiveness of a polyherbal formulation (GP/PROD/2021/004) versus StandardAllopathic Formulation for relief of acute nonproductive cough and throatirritation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
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 with H/O acute nonproductive cough and throat irritation for less than 1week duration Males and Females between 18-65 years age Patients who in the opinion of the Investigator will be able to comply with the study requirements Patients with a cough score of 0, 1 or 2 during day time Patients willing and able to provide signed informed consent for any study related procedures.
排除标准
- •Patients with H/O lower respiratory tract infections such as Pneumonia, Tuberculosis, Bronchitis, Whooping cough.
- •Patients with H/O Chronic Obstructive Pulmonary Diseases/Asthma Patients with H/O underlying lung pathology such as lung abscess, cystic fibrosis.
- •Patients with known hypersensitivity to ingredients of Investigational Products Patients with clinical suspicion of any systemic bacterial infection.
- •Patients with H/O Myocardial Infarction (MI) within 4 weeks prior to enrollment Patients with immediate life threatening diseases such as pre-existing cardiovascular, liver or neoplastic disease.
结局指标
主要结局
1. Changes in day and night frequencies of cough from baseline to end of treatment period on a 6-point scale
时间窗: Baseline Day, Day 1, Day 2, Day 3, Day 4, Day 5, and Day 15
2. Change in throat irritation from baseline to end of treatment period on a 5-point scale
时间窗: Baseline Day, Day 1, Day 2, Day 3, Day 4, Day 5, and Day 15
次要结局
- 1.Time to relief from cough and throat irritation on 5 point scale for first morning dose over a treatment period of 5 days(2.Duration of relief from symptoms on a 5 point scale for first morning dose over a treatment period of 5 days)
研究者
研究点 (2)
Loading locations...
相似试验
招募中
不适用
management of hypothyroidism through polyherbal medicineCTRI/2019/07/020457Rishikul campus30
已完成
不适用
A clinical study to assess effect of an herbal product in improving testosterone levels in healthy young malesCTRI/2018/11/016337Laila Nutraceuticals120
已完成
不适用
RCT of a Polyherbal Dietary Supplement for PrediabetesPrediabetic StateNCT03388762University of Maryland, Baltimore39
招募中
2 期
Study on herbal neutraceuticals in delivering physical energyCTRI/2023/02/049575MVR Ayurveda medical college and hospital40
已完成
2 期
A clinical study to compare the effect of extract and crude form of Unani drug in the treatment of Gouty Arthritis.CTRI/2020/10/028663Ayurvedic and Unani Tibbia College Hospital40