Observational Study on cough syrup
- Conditions
- Health Condition 1: null- 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
- Registration Number
- CTRI/2015/09/006198
- Lead Sponsor
- Dr Reddys laboratories Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 250
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method