CTRI/2015/09/006198已完成未知
Assessment of Efficacy, Safety and Tolerability of therapy with fixed dose combination (FDC) of Cetirizine with Ambroxol and Ambroxol as monotherapy in the treatment of productive Cough: An Open-label, Prospective, Multi-centre, Observational Study
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1. Children between over 6 to 18 years of age
- •2. Male and female children
- •3. Children having productive cough (cough with expectoration)
- •associated with any of the nasal symptoms (nasal discharge,
- •nasal stuffiness, nasal itching, and Sneezing) since at least
- •previous 8 hours
- •4. Child willing to provide assent and parents/guardian willing
- •to provide written informed consent
- •5. Willing and able to understand and comply with all study
- •requirements
排除标准
- •1.Use of any throat lozenge, throat spray, cough drop, menthol-containing product, or any product with demulcent properties within last 8 hours
- •2.Use of any cold medication (e.g. nasal or systemic decongestants, antihistamine, expectorant, anti-tussive) within last 8 hours
- •3.Severe cough requiring hospitalization
- •4.Presence of fever within last 8 hours
- •5.Active pulmonary disease such as bronchopneumonia, bronchial asthma or tuberculosis
- •6.Known allergy to and/or hypersensitivity to ambroxol and/or cetirizine
- •7.Any other condition, which in the opinion of the clinician/investigator, could interfere significantly with the treatment and assessment process
- •8.Use of any investigational therapy within 30 days prior to randomization
- •9.Child not willing to provide assent and parents/guardian not willing to provide written informed consent
研究者
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