Health Condition 1: J00- Acute nasopharyngitis [common cold]
Conditions
Interventions
Intervention1: FLUCOLD SYRUP: 5 mL syrup every four to six hours up to a maximum of six doses in 24 hours for three days.
Control Intervention1: Not applicable: Not applicable
Sponsors
Wallace Pharmaceuticals Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Children with the age of 2 to 12 years. 2.Presented symptoms of recent onset, for more than 6 hours and less than 72 hours, characterizing one of the following conditions: the common cold, which consists of at least 2 symptoms among the 10 following: sneezing, rhinorrhea, nasal congestion, headache, muscle pain, discomfort in the throat, sore throat, dysphonia, cough, fever, the latter being of moderate to severe intensity through a symptom severity scale of 4 points The flu syndrome, which consists of high grade up to 104 .F and headache of moderate or severe intensity or chest discomfort, decrease appetite, dizziness using a scale of severity of symptoms of 4 points 3.Willing to provide written assent form by parents for participation in the study and adhere to the protocol requirements.
Exclusion criteria
Exclusion criteria: 1.Patients representative who are not willing to give written assent form. 2.Any known hypersensitivity to the study products. 3.Any history of seasonal or perennial allergic rhinitis. 4.Patients who have taken treatment for the presenting symptom within 7 days of screening. 5.Patients who received influenza vaccine within 7 days of screening. 6.Patients who in the opinion of attending physician may need receive antibacterial drugs for the treatment of acute respiratory infection. 7.Any lab findings or clinical findings that in the opinion of treating physician may appear as risk to the patient. 8.Participation in any clinical trials prior to 12 months. 9.Any finding of clinical observation that is interpreted by the physician investigator as a risk to the patients participation in the study. 10.Severely immune compromised patients. 11.Use of any investigational drug currently or within 30 days prior to study entry. 12.Subjects on any prescription medication that might interfere with study outcomes. 13.Patients with severe hepatic, renal insufficiency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rates of Treatment ââ?¬â?? emergent adverse events and serious adverse eventsTimepoint: baseline Day 1, Day 4 and Day 9 | — |
Secondary
| Measure | Time frame |
|---|---|
| ââ?¬Â¢Assess the symptomatic relief of common cold and flu syndrome. ââ?¬Â¢Significant changes in VAS scores from baseline to EOT. ââ?¬Â¢Tolerance of IP ââ?¬Â¢Assessment of safety of Investigational product. I. Adverse event II. Physical examination III. Biomarker of systemic safety - Hematological test - Liver function test - Kidney function testTimepoint: baseline Day 1, Day 4 and Day 9 | — |
Countries
India
Contacts
Public ContactDr Harish S
ICBio Clinical Research Pvt. Ltd.
Outcome results
None listed