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

Study of the effect of European propolis hydro-alcoholic extract chemically characterized with high polyphenols content (SPRAY PROPOLIS URTI) on the first symptoms of mild uncomplicated upper respiratory tract infections: a double-blinded, placebo-controlled, parallel-group, single-center study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17594930

Enrollment

122

Registered

2020-03-27

Start date

2019-12-19

Completion date

Unknown

Last updated

2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uncomplicated mild upper respiratory tract infections Respiratory

Interventions

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 up

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Individuals with allergies, which could be confused with those with irritation upper airway, object of study 2. Immunocompromised subjects 3. Subjects under immunological therapy 4. Subjects who received antibiotic therapy within 72 hours prior to enrollment 5. Pregnant women 6. Breastfeeding women 7. All patients with overt malignant neoplasia, recent cardio-cerebro-vascular diseases (within 90 days prior to enrollment), with severe middle renal; insufficiency (ascertained with creatinine clearance), and non-autonomous 8. All subjects who according to the doctors are not eligible to participate in the study in question

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Italy

Contacts

Public ContactCristina Esposito

cristina.esposito@unina.it+39 (0)81678644

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026