CTRI/2020/06/026248
Completed
Phase 4
A Prospective, Interventional, Multicenter, Post marketing Clinical Study of fixed dose combination of FLUCOLD SYRUP (Paracetamol 125 mg + Phenylephrine HCL 5 mg + Chlorpheniramine maleate 1 mg + sodium citrate 60 mg per 5 mL) syrup of Wallace Pharmaceutical Pvt. Ltd in the Treatment of common cold and flu syndrome in children
Wallace Pharmaceuticals Pvt Ltd0 sites204 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Wallace Pharmaceuticals Pvt Ltd
- Enrollment
- 204
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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