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
Conditions
Interventions
Intervention1: Relent Plus syrup by Dr Reddys: Ambroxol+cetrizine
Control Intervention1: Mucolite syrup by Dr Reddys: Ambroxol
Sponsors
Dr Reddys laboratories Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Total Symptom Score (TSS) for cough would be sum total of four scores given below: o Sputum volume, o Sputum viscosity, o Difficulty of expectoration, and o Severity of cough All above symptoms would be assessed on a 4-point scaleTimepoint: 1) 3rd day visit 2) 7th day visit | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Total Nasal Symptom Score (TNSS) which is the sum total of scores for the following symptoms: o Nasal discharge, o Nasal stuffiness, o Nasal itching, and o Sneezing 2. Cough frequency (daily) assessed during follow-up visit 3. Number of awakenings in the night due to cough (24 hours) assessed during follow-up visit 4. Time taken for complete cough relief (days) assessed during follow-up visit Timepoint: 3rd Day 7th day | — |
Countries
India
Contacts
Public ContactDr Sachin Aggrawal
Dr Reddys Laboratories Ltd
Outcome results
None listed