Authors
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Hospital das Clínicas de Porto Alegre -More
Category
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Primary study
Registry of Trials»Brazilian Registry of Clinical Trials
Year
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2017
INTERVENTION: D02.033.100.291.617 D02.065.199.092.040 D03.383.725.620.150 Experimental group: 155 adults with flu/cold symptoms treated with one tablet of 400mg of paracetamol + 4 mg chlorpheniramine maleate 4mg + phenylephrine hydrochloride four times a day, for 3 days. Control group: 155 adults with flu/cold symptoms treated with 1 capsule of 400mg paracetamol + 4 mg chlorpheniramine maleate 4mg + phenylephrine hydrochloride every four hours, up to 5 capsules daily maximum, for 3 days. CONDITION: C02.782.620.375 C02.782.687.207 Flu, Commom Cold. ; C02.782.687.207 ; C02.782.620.375 J00‐J99 PRIMARY OUTCOME: Clinical level variation of the 10 main symptoms of flu or cold (runny nose, muscle aches, fever, headache, nasal congestion, cough, dysphonia, sore throat, throat irritation, sneezing) assessed by the investigator using the Likert scale (score 0 = without symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms) after 72h of treatment.; The clinical level is measured by the sum of the scores of the top 10 symptoms of cold or flu, ranging from 0 to 30, corresponding to 0 absence of any symptoms and 30 to the maximum level of severity of all symptoms. SECONDARY OUTCOME: Average reduction of the global scale of 10 symptoms between baseline and 72 hours of treatment. Clinical level variation of the 10 major symptoms of cold or flu evaluated by researcher using the Likert scale at the end of the study (telephone contact). General health conditions of the research participants, evaluated through the Likert scale at all times of the study. Mean reduction of the overall scale of 10 symptoms between baseline and end of study. Measurement by symptom of each of the 10 main symptoms of cold or flu evaluated by researcher using the Likert scale at the end ; study (telephone contact). Measurement by symptom of each of the 10 major symptoms of cold or flu evaluated by the investigator through the Likert scale, after 72h treatment. Overall assessment of the treatment regarding the improvement of the participants and researcher through Likert scale, after 72 hours of treatment. Proportion of adherence to the treatment, evaluated by the medication count that was not used by the research participants, which should be returned to the center, calculated by the ratio between the medication actually observed and the expected medication. Values 75% of the individual proportion of adhesion will be considered a good adhesion. INCLUSION CRITERIA: Adults; Both genders; Age between 18 and 60; Patients diagnosed with flu or cold with congestive and exudative symptoms such as corizas, muscle aches, fever, headache, nasal congestion and other symptoms present in Influenza like illness; Women of childbearing potential should be sexually inactive or be using one of the acceptable methods of contraception; Women without childbearing potential must be surgically sterile or already have over 2 years post‐menopause.
Epistemonikos ID: e6018a58654fc0499f90e7af091ffe4dc48a4188
First added on: Aug 23, 2024