Phase III longitudinal, multicenter, randomized, double-blind clinical trial. The aim of this study is to evaluate the efficacy and safety of the drug combination of Ibuprofen/Loratadine versus Ibuprofen versus Loratadine as monotherapy for the symptomatic treatment of the common cold.
Agree to participate in the study and give written informed consent
At least 6 points on the Jackson scale according to physical examination and questioning (sneezing, runny nose, nasal obstruction, sore throat, cough, headache, malaise, and chills).
Symptoms associated with the common cold with maximum of 3 days since presentation
Women of childbearing potential under a medically acceptable method of contraception
Patients in whom respiratory symptoms are suspected to be of bacterial origin and generate a clinical picture compatible with: Rhinosinusitis (muco-purulent discharge, headache or facial pain, etc.), lower respiratory tract disease (wheezing, crackles, productive cough, etc.), acute otitis media (otalgia, purulent discharge from the ear, auditory discomfort, etc.).
Patients participating in another clinical trial involving an investigational treatment or participation in one within 4 weeks prior to study start
Patients in whom participation in the study may be influenced (employment relationship with the research site or sponsor, inmates, etc.)
At medical discretion, a disease that affects prognosis and prevents outpatient management, for example, but not limited to: end-stage cancer, kidney, heart, respiratory or liver failure, mental illness or with scheduled surgical or hospital procedures
Parallel
Ibuprofen + Loratadine fixed dose
DrugSuspension 8,000 mg / 100 mg / 100 mL, 5 mL twice a day
Ibuprofen
DrugSuspension 2,000 mg / 100 mL, 20 mL twice a day
Loratadine
DrugSuspension 1 mg / 1 mL, 5 mL twice a day
Assess the improvement in symptoms, comparing the percentage change through the Jackson score
The Jackson score is calculated by summing 8 symptom scores (sneezing, headache, malaise, chilliness, nasal discharge, nasal obstruction, sore throat and cough), rated as 0=absent, 1=mild, 2=moderate, and 3=severe.
Number of participants with treatment-related adverse events through the patient's diary record, by treatment group
To describe the frequency, intensity and causality of the adverse events presented during the clinical trial by treatment group. The adverse events will be registered by the patient in the diary record. Each adverse event will be followed up at the discretion of the researcher
Assess the subjective change in patients in relation to quality of life through the modified Likert score
To compare quality of life measured as a difference in the modified Likert score by treatment group during the 7 days after starting treatment with respect to the baseline measurement. The patient will answer the scale daily. The Likert Scale is a seven point scale that is used to allow an individual to express how much they agree or disagree with a particular statement. The scale consists of 1 question associated to quality of life. The possible answers go from No interference to Severe interference.
Assess the subjective change in patients in relation to improvement in symptoms through the Subjective Global Scale
Assess the improvement in symptoms measured as the proportion of patients who present a change in the Global Subjective Scale during the 7 days after starting treatment with respect to the baseline measurement. The subjective global scale for symptom improvement compares with the score of the previous day to determine health status daily. Is consists of 1 question related to the progress in the symptoms presentation, the answers go from much better to really worse.
Assess the improvement in health status through the modified Likert Scale
To compare improvement in health status as a difference in the modified Likert scale by treatment group during the 7 days after starting treatment with respect to the baseline measurement.The patient will answer the scale daily. The Likert Scale is a seven point scale that is used to allow an individual to express how much they agree or disagree with a particular statement. The scale consists of 1 question associated to the health status of the patient. The possible answers go from Not feeling sick to feeling to Severely sick.
Assess the percentage of patients with febrile episodes (≥38°C) during the intervention
The patient will report the presence of fever during the intervention, quantified with a thermometer.
To report the percentage of therapeutic adherence at day 7 of intervention by group of treatment
Adherence to treatment will be defined as a consumption ≥ 80% of the doses that the patient should have ingested at the time of the corresponding evaluation
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