The beneficial effect of resin-like material made by bees (European propolis hydroalcoholic extract) on the first symptoms (sore throat, muffled dysphonia, and swelling and redness of throat) of mild bacterial and viral infections of the upper respiratory tract

INTERVENTION: Participants are randomly allocated into two experimental groups: placebo and propolis. t0 (i.e. before the treatment start). Patients with symptoms reflecting a mild uncomplicated upper respiratory tract infection which meet the inclusion criteria are examined for the symptom assessment. The patient is expected to perform the oropharyngeal swab (followed by antibiogram if positive). Treatment: administration (2‐4 times/day) of propolis oral spray or placebo spray for 5 days. If after 3 days of treatment with propolis or placebo at t1 (3 days after the follow‐up visit) fever appears the patient has to be submitted to a visit to evaluate the type of therapeutic treatment to be administered. If after 5 days of treatment with propolis or placebo at t2 (after 5 days from the start of treatment ie at the end of the treatment) the symptoms and/or fever appears the patient has to be submitted to a visit to evaluate the type of therapeutic treatment administered (the subject is excluded from the clinical trial). Follow up: t3 monitoring (15 days after the end of propolis or placebo treatment). The randomization sequence will be generated by a statistician using STATA 16 software (Stata Statistical Software: Release 16. College Station, TX: StataCorp LLC), and subjects (compliant to the inclusion and exclusion criteria) will be assigned to each of the two treatment groups (propoli and placebo) randomly and unpredictably by simple randomization (1:1 allocation ratio). The randomization code will consist of a three‐digit number as indicated in the respective Case Report Form (CRF). CONDITION: Uncomplicated mild upper respiratory tract infections ; Respiratory PRIMARY OUTCOME: The presence of sore throat, muffled dysphonia and swelling and redness of throat measured by the physician at baseline (t0), t1(after 3 days), t2 (after 5 days) SECONDARY OUTCOME: ; Bacteria susceptibility test performed at t0 (enrollment time) and t3 (after 15 days).; ; The Kirby‐Bauer method was used to determine susceptibility to antibiotics of the bacteria occurring in the biological material taken from throat swab. The medium used is Mueller‐Hinton agar. To prepare the inoculum, 4‐5 colonies grown on the primary isolation medium, are suspended in 4‐5 ml of Tryptic Soy Broth (enrichment broth), incubating for 2‐6 hours.; 1. A bacterial suspension adjusted at 0,5 MacFarland standard (see Clinical Laboratory Standards Institute document) is inoculated with a sterile swab on MH agar surface.; 2. Antimicrobial‐impregnated disks were placed on agar surface, using a sterile tweezers.; 3. Plates were incubated at 37°C for 24 hours.; 4. Tests were evaluated by diameter alone inhibition around disks.; Reading an antibiogram:; Resistant bacterium: 1 ‐ 9 mm halo; Bacterium with intermediate resistance: 10 ‐ 18 mm halo; Sensitive bacterium: 19 ‐ 30 mm halo; INCLUSION CRITERIA: Current inclusion criteria as of 05/08/2020: 1. Aged 18 ‐ 77 years of age 2. Affected by the first symptoms of mild uncomplicated upper respiratory tract infections Previous INCLUSION CRITERIA: 1. Aged 18 ‐ 65 years of age 2. Affected by the first symptoms of mild uncomplicated upper respiratory tract infections