CTRI/2016/09/007265尚未招募未知
A Comparative, Randomized, Double Blind, Parallel Group, Observational Clinical Trial Study to Evaluate Efficacy and Safety of a Filmogen Glycerol Throat Spray Containing Cw-Cyanidin Plant Premix Versus Saline Spray as Placebo in the treatment of patients Suffering from Wet (Productive) Cough - Wet cough
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- VITROBIO
- 入组人数
- 63
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Both male and female, Age between 08 to 65 years old.
- •Patients having acute moderate to severe wet (productive) cough (onset of bronchial mucus production at a maximum of 7 days prior to screening of any origin with related symptoms as 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 patientâ??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.
排除标准
- •Hypersensitivity/ history of allergy to any of the Investigational productâ??s components.
- •Those who had taken any medicated confectionary, throat pastille, spray, or any product with demulcent properties, expectorants, mucolytic drug, any cough medicines or drugs containing antihistamines within last 72 hours prior to screening and during study.
- •Participants with unproductive cough (dry cough)
- •Patients taking medications with known cough promoting side effects (e.g., angiotensin converting enzyme inhibitors or angiotensin II receptor blockers) that in the opinion of the investigator are causing symptoms of cough
- •Patients with diagnosis of diseases of pneumonia, asthma, sinusitis, allergic rhinitis, as well as heart disease.
- •Patients who had used any local anesthetic within the past 24 hours.
- •Patients who have used a longer acting or slow release analgesic during the previous 24 hours.
- •Patients taking antibiotics during the previous 14 days.
- •Patients with a history of severe renal impairment, hepatic impairment.
- •Patients with a history of alcohol abuse or who stated that they regularly consume alcohol in excess of the recommended amounts (excessive alcohol greater than 21 units per week for females and greater than 28 units per week for males).
- •Patients unable to refrain from smoking during their stay in the investigative site.
- •Patient who is pregnant, nursing, or a woman of childbearing potential not practicing adequate contraception. Women, who are uncertain if they are pregnant, may participate in the study, if they undergo a pregnancy test, which shows a negative result.
研究者
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