Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT02904304
Eligibility Criteria:
Inclusion Criteria:
* Age older or equal to 18 and younger than 66 years;
* Subjects diagnosed with common cold / flu syndrome defined by clinical evaluation and the presence of two or more of the following symptoms: sneezing, rhinorrhea, nasal obstruction, headache, throat discomfort, sore throat, dysphonia, myalgia, cough and fever classified as moderate or intense in four intensity scale (04) items (0 = absent, 01 = light, 02 = moderate, 03 = severe);
* Beginning of the symptoms of common cold / flu-like syndrome in a minimum period of 24 hours and a maximum of 72 hours prior to V0;
* Ability to understand and consent to participate in this clinical research, expressed by signing the Informed Consent Form (ICF);
Exclusion Criteria:
* Any laboratorial finding (clinical evaluation / physical evaluation / vital signs / ECG changes) that the Investigator consider a risk to subject of the study;
* Hypersensitivity to the drug components used during the study;
* Women in pregnancy or nursing period;
* Women in reproductive age who do not agree to use contraception acceptable \[oral contraceptives, injectable contraceptives, intrauterine device (IUD), hormonal implants, barrier methods, hormonal patch and tubal ligation\]; other than surgically sterile (bilateral oophorectomy or hysterectomy), postmenopausal for at least one (01) years or sexual abstinence;
* Subjects that has participated in clinical trial protocols in the last twelve (12) months (National Board of Health- Resolution 251 of 07 August 1997, Part III, sub-item J), unless the investigator considers that there may be a direct benefit to it;
* Alcohol abuse that, according to the investigator, may interfere with the pharmacological adherence to the clinical protocol;
* Any medical conditions which may interfere with efficacy and / or safety of the treatment with the investigational product, such as but not limited to disorders described below:
* Untreated or uncontrolled Hyperthyroidism
* Uncontrolled epilepsy
* diagnosis of glaucoma
* Moderate or severe persistent asthma (untreated or uncontrolled)
* NSAID-induced asthma diagnosed
* Systemic hypertension (SH) stage III uncontrolled
* Moderate and severe congestive heart failure
* Acute myocardial infarction
* unstable angina
* Uncontrolled cardiac arrhythmia
* Liver failure with clinical consequences
* Renal failure with clinical consequences
* Diagnosed HIV positive
* uncontrolled Diabetes type 1 or type 2
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02904304
Study Brief:
Protocol Section:
NCT02904304