Flu, Commom Cold.
Conditions
Interventions
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.
Co
Drug
D03.383.725.620.150
Sponsors
Hospital das Clínicas de Porto Alegre
Scentryphar
Hospital Vera Cruz
Instituto São José dos Campos em Pesquisas Médicas
Clínica de Alergia Martti Antila
Instituto de Moléstias Cardiovasculares de Tatuí
Eligibility
Age
18 Years to 60 Years
Inclusion criteria
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.
Exclusion criteria
Exclusion criteria: History of hypersensitivity to the components of the study formulations; history of alcohol or drug abuse; bronchial asthma, severe kidney or liver disease, high blood pressure, heart disease, diabetes, thyroid dysfunction, glaucoma or prostatic hypertrophy; history of asthma maintenance therapy and/or asthma attacks in the last 5 years; clinical evidence of immunosuppression; use of monoamine oxidase inhibitor medicines (eg .: phenelzine, iproniazid, isocarboxazid, harmaline, nialamide, pargyline, selegiline, toloxatone, tranylcypromine, moclobemide); surgery or dental intervention with general or spinal anesthesia; be vaccinated against the flu less than 1 week prior to study enrollment; use of tricyclic antidepressants (amitriptyline, clomipramine, imipramine), barbiturates or oral anticoagulants; pregnant or nursing women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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.;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).;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).;Mean reduction of the overall scale of 10 symptoms between baseline and end of study.;General health conditions of the research participants, evaluated through the Likert scale at all times of the study.;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. | — |
Countries
Brazil
Contacts
Public ContactJoão Antonio Fittipaldi
BRAINFARMA INDUSTRIA QUIMICA E FARMACEUTICA S.A.
Outcome results
None listed