Health Condition 1: J00- Acute nasopharyngitis [common cold]
Conditions
Interventions
Intervention1: Grilinctus Syrup: Dose: Children 4 â?? 6 years â?? 5 ml (One teaspoonful) every 4 to 6 hours or as advised by physician.
Children above 6 years â?? 10 ml (two teaspoonful) every 4 to 6
Sponsors
Franco Indian
Eligibility
Inclusion criteria
Inclusion criteria: 1. Childrenâ??s of either sex having age group 4-10 years (both inclusive). 2. Childrenâ??s presenting with symptoms of acute common cold prevailing for less than 48 hours 3. Childrenâ??s that are having the four symptoms of Common cold. Sneezing, Nasal obstruction, Nasal discharge, Sore throat, Chilliness, Headache, fever and Cough. 4. Childrenâ??s having systemic symptom score 5. Patient able to understand and follow study procedures agrees to participate in the study by giving his/her written informed consent.
Exclusion criteria
Exclusion criteria: 1. Children with asthma requiring treatment or had required emergency treatment within 1 month. 2. Hospitalization 3 months prior to the trial. 3. Suspected bacterial infections, recent use of antimicrobial drugs, and intranasal treatment at first presentation. 4. Patient requiring, corticosteroids, cromolyn sodium, nedocromil and inhaled cholinergics, oral or long acting beta-agonist, theophylline and other leukotriene modifiers. 5. History of hypersensitivity to any ingredient of the investigational product. 6. If has any form of Psychiatric Illness and undergoing treatment for the same. 7. If has taken immunosuppressive therapy or steroids as treatment in the last 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in systemic symptom score at the end of the study as compared with baseline.Timepoint: Change in systemic symptom score at the end of the study as compared with baseline. When the systemic symptom score is less than or equal to 4 treatment will be stopped. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in local symptom score at the end of the study as compared with baseline. 2. Change in QOL questionnaire for cough. 3. Physician and Subject Global assessment.Timepoint: For the entire duration of treatment (7 days). | — |
Countries
India
Contacts
Public ContactDr Rekha Shetty
Franco Indian
Outcome results
None listed