An Open-label, single-arm clinical trial to evaluate Efficacy and Safety of Hariras Ayurvedic pills for symptomatic relief of acute nonproductive Cough and Throat Irritation
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 1. Change 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
After receiving Ethics committee’s approval for study protocol, clinical study will be registered on CTRI website.
Male and female subjects between 18 to 65 years of age with history of acute nonproductive cough and throat irritation for less than 1week duration will be screened for eligibility criteria.
On screening visit, a written informed consent will be obtained from subject confirming participation in the study. Subject’s medical and medication history and demographic details will be taken. Subject’s current medication if any will be noted in the case record from (CRF). Physical examination and vitals will be recorded. The subject will be considered for further evaluation as per the inclusion and exclusion criteria.
On the Baseline visit, subjects will be recruited in the study if they meet all the inclusion criteria and will then be randomized to the respective study groups as per the computer-generated randomization list.
At the Baseline visit, cough frequency during day and night will be recorded. Throat irritation and other symptoms will be assessed on a 5-point scale.
The subject will be provided with investigational products and advised to consume One Hariras pill 08 to 10 times per day of investigational product.
Subjects will be called at respective study sites for follow-up visits on Days 2 and 5.
At each follow-up visit, cough frequency during day and night will be recorded. Throat irritation and other symptoms will be assessed on a 5-point scale. Drowsiness will be assessed on 2-point scale. Clinical signs and symptoms related to acute nonproductive cough will be assessed on a 5-point scale.
After completion of 5 days of study treatment, response to treatment will be assessed based on changes in the frequency of cough and throat irritation from the Baseline to the end of Day 5 in both the treatment groups.
The subject will be asked to stop the investigational product and take the advice of the investigator for further treatment. Post-study safety evaluations will be done**.**
The subject will be closely monitored for any adverse event starting from the baseline visit till the end of the study visit.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female subjects (18 to 65 years of age) with history of acute nonproductive cough and throat irritation for less than 1week duration
- •Subjects with a cough score of 0, 1, or 2 during daytime
- •Subjects willing and able to provide signed informed consent forms before any study-related procedures.
- •Subjects willing to abstain from other medication (allopathic or herbal) for cough treatment during the study period
- •Subjects who in the opinion of the Investigator will be able to comply with the study requirements.
排除标准
- •Subjects with a history of lower respiratory tract infections such as Pneumonia, Tuberculosis, Bronchitis, and Whooping cough.
- •Subjects with a history of Chronic Obstructive Pulmonary Diseases, Asthma
- •Subjects with a history of underlying lung pathology such as lung abscess, or cystic fibrosis.
- •Subjects with known hypersensitivity to any ingredients of the investigational products
- •Subjects with clinical suspicion of any systemic bacterial infection.
- •Subjects with a history of Myocardial Infarction (MI) within 4 weeks before enrollment
- •Subjects with immediate life-threatening diseases such as pre-existing cardiovascular, liver or neoplastic disease.
- •Subjects who had received any sedative, hypnotic or tranquilizer within 14 days before randomization
- •Subjects who had received any of the anti-histamines, cough suppressants, mucolytics, expectorants, or antibiotics within 3 days before randomization.
结局指标
主要结局
1. Change in day and night frequencies of cough from Baseline to end of treatment period on a 6-point scale
时间窗: At Screening, Baseline, Day 1, Day 2, Day 5
2. Change in throat irritation from Baseline to end of treatment period on a 5-point scale
时间窗: At Screening, Baseline, Day 1, Day 2, Day 5
次要结局
- 1. Time to relief from cough & throat irritation on a 5-point scale for first morning dose over a treatment period of 05 days(2. Duration of relief from symptoms (related to acute nonproductive cough) on a 5-point scale for first morning dose over a treatment period of 5 days)
研究者
Dr Amol Gothwad
Lokmanya Medical Research Centre and Hospital