Parallel arm, prospective, randomized study for clinical effectiveness of TR-01 in providing relief in productive, non-productive and chronic bronchial cough with throat irritation.
试验速览
- 阶段
- 1/2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- To assess the efficacy of herbal syrup with respect to symptomatic relief in patient suffering from cough.
研究概览
简要总结
TR-01 is a well developed polyherbal cough syrup formulation with potential to work in productive, non productive and bronchial cough.
The present study aims at conducting clinical validation of the relief in cough and related symptoms, safety, tolerability and adverse effects if any.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 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
- •Male and females between 18 to 65 years age.
- •Patients diagnosed as having cough with one of the following conditions a.
- •Patients having dry cough (less than 14 days) of any origin b.
- •Patients having acute moderate to severe wet (productive) cough production at a maximum of 14 days prior to screening of any origin c.
- •Diagnosis of chronic bronchitis (chronic cough and sputum production on most days for one consecutive months for more than two consecutive years).
- •Presenting symptoms of Throat Pain, throat redness, Throat irritation/itching, (Fever if present).
- •Not under any antibacterial or antiviral treatment before recruitment.
- •Patients ready to abstain from using any drug (which will affect the study outcome) other than Investigational
- •Product for the treatment of the studied condition during the study period except in cases if patient’s condition worsen (At the discretion of study physician antibiotic will be prescribed if required).
- •Ready to abstain from administration of any herbal or ayurvedic treatment or gargles directed to ease coughing or throat parameters, tea, coffee.
- •Cooperative and understanding skills.
- •Patient willing and able to provide a signed written informed consent prior to any study – specific procedure.
- •Patients who in opinion of the investigator will be able to comply with the study requirements.
排除标准
- •Patients with H/O underlying lung pathology such as lung abscess, cystic fibrosis.
- •Patients with known hypersensitivity to ingredients of Investigational Products
- •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.
- •Patients with uncontrolled Hypertension.
- •Alcohol, smoke and drug abusers will be excluded.
- •Occasional users of cigarettes and alcohol may participate in the study as per the investigators discretion.
- •Such participants should be instructed from restricting the use of cigarettes / alcohol during the study participation period.
- •Subjects on any other herbal therapy / supplement for cough
- •Patients with history of hepatic impairment
- •Pregnancy, lactation and female patients not using acceptable contraceptive measures.
- •Participation in another clinical trial in the past 3 months
- •Known human immunodeficiency virus (HIV), Hepatitis B virus (HBV), Hepatitis C virus (HCV), or tuberculosis infection.
结局指标
主要结局
To assess the efficacy of herbal syrup with respect to symptomatic relief in patient suffering from cough.
时间窗: At day 0, 1,4 and at day 8. Minimum 4 days and maximum 8 days or up to complete recovery (whichever is earlier) compared to the baseline.
Change in the wet cough severity and frequency score
时间窗: At day 0, 1,4 and at day 8. Minimum 4 days and maximum 8 days or up to complete recovery (whichever is earlier) compared to the baseline.
Change in the dry cough severity and frequency score
时间窗: At day 0, 1,4 and at day 8. Minimum 4 days and maximum 8 days or up to complete recovery (whichever is earlier) compared to the baseline.
Change in the bronchial cough severity and frequency score
时间窗: At day 0, 1,4 and at day 8. Minimum 4 days and maximum 8 days or up to complete recovery (whichever is earlier) compared to the baseline.
次要结局
- Leicester Cough Questionnaire(Change in the Chest discomfort score)