A Multicentre Double Blind Parallel Group two Arm Randomized Clinical Study To Evaluate The Safety And Efficacy Of Dabur Honitus Syrup Versus Benadryl Cough Formula Syrup For Symptomatic Relief Of Acute Non Productive Cough And Throat Irritation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 3
- 主要终点
- Changes in day and night frequencies of cough from baseline on a 6 point scale in
研究概览
简要总结
This is a multicenter, double blind; two arm randomized, parallel group clinical study to evaluate the safety and efficacy of a polyherbal formulation Dabur Honitus versus Standard Allopathic Formulation for symptomatic relief of acute non productive cough and throat irritation. The study will be conducted across 3 centers in India. Approximately 110 subjects will be enrolled, 55 receiving the study drug and 55 receiving the reference comparator drug. Males and females between 18-65 years with acute non productive cough and throat irritation of less than 1 week duration and meeting the selection criteria will be enrolled. Screening/baseline procedures will include medical history, physical examination and vital signs. Assessment for clinical signs and symptoms, vitals and Adverse Events will be done at every follow up visit on Day 2, Day 3 and Day 4 post treatment. Response to treatment will be measured by change in frequency of cough and throat irritation from the baseline value to end of 3day treatment in both the treatment arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
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 non productive cough and throat irritation for less than 1 week 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 form prior to 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.
- •Patients with Hypertension on Angiotensin-converting enzyme (ACE) inhibitors.
- •Alcohol, smoke and drug abusers will be excluded.
- •Occasional users of cigarettes and alcohol may pariticpate in the study as per the investigator’s discretion.
- •Such participants should be instructed from restricting the use of cigarettes / alcohol during the study participation period.
- •Patients participating in any other clinical trial.
- •Pregnant or lactating females.
- •Patients who have received any immunosuppressant, Sedative, Hypnotic or Tranquilizer 14 days prior to enrollment.
- •Patients who have received any Anti Histaminics, Cough suppressants , Mucolytics , Expectorants or Antibiotics 3 days prior to enrollment.
- •Any other condition due to which patients are deemed to be unsuitable by the Investigator for reason (s) not specifically stated in the exclusion criteria.
- •Patients with H/O Parkinson’s disease who are on Mono Amine Oxidase Inhibitors (MAO) inhibitors.
- •Any psychiatric illness which may impair the ability to provide written informed consent.
结局指标
主要结局
Changes in day and night frequencies of cough from baseline on a 6 point scale in
时间窗: Changes in day and night frequencies of cough from baseline on a 6 point scale in | patients with acute non- productive cough receiving therapy over a period of 3 | days and Change in throat irritation on a 5 point scale from 0-4 over a treatment period of | 3 days
patients with acute non- productive cough receiving therapy over a period of 3
时间窗: Changes in day and night frequencies of cough from baseline on a 6 point scale in | patients with acute non- productive cough receiving therapy over a period of 3 | days and Change in throat irritation on a 5 point scale from 0-4 over a treatment period of | 3 days
days and Change in throat irritation on a 5 point scale from 0-4 over a treatment period of
时间窗: Changes in day and night frequencies of cough from baseline on a 6 point scale in | patients with acute non- productive cough receiving therapy over a period of 3 | days and Change in throat irritation on a 5 point scale from 0-4 over a treatment period of | 3 days
3 days
时间窗: Changes in day and night frequencies of cough from baseline on a 6 point scale in | patients with acute non- productive cough receiving therapy over a period of 3 | days and Change in throat irritation on a 5 point scale from 0-4 over a treatment period of | 3 days
次要结局
- Time to relief from cough and throat irritation on a 5 point scale for first morning dose over a treatment period of 3 days, Duration of relief from symptoms on a 5 point scale for first morning dose over a treatment period of 3 days, Measure of drowsiness on a 2 point scale and Physician’s global assessment of efficacy on a 5 point scale(Time to relief from cough and throat irritation on a 5 point scale for first morning dose over a treatment period of 3 days, Duration of relief from symptoms on a 5 point scale for first morning dose over a treatment period of 3 days, Measure of drowsiness on a 2 point scale and Physician’s global assessment of efficacy on a 5 point scale)