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
| ISRCTN | ISRCTN17594930 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17594930 |
| Secondary identifying numbers | PROURTI0119 |
- Submission date
- 21/03/2020
- Registration date
- 27/03/2020
- Last edited
- 19/11/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English Summary
Background and study aim
The effects of cold and flu on the mouth, throat, and windpipe (upper respiratory tract infections) are very common and are one of the most frequent causes of the doctor's consultation.
Propolis (also known as bee resin) is the generic name used to identify a natural, resinous substance collected by bees (Apis mellifera) from buds and exudates of different plant species consisting of resin (50%), waxes (30%), essential oils (10%), pollen (5%), and other compounds including minerals and organic compounds. Propolis exerts a number of biological properties such as anti-inflammatory and antimicrobial activity. Propolis also has an effect on the respiratory system, as such, it can significantly reduce the number and nocturnal asthma attacks severity. It is able to improve lung function and reduce inflammation defence mechanisms. European propolis hydroalcoholic extract with a high content of polyphenols will be used in the present clinical study to treat mild upper respiratory tract infection.
Who can participate?
Individuals affected by the first symptoms of mild uncomplicated upper respiratory tract infections, aged 18 - 77 years old (updated 05/08/2020, previously: 18 - 65 years old.)
What does the study involve?
Participants are randomly allocated into two experimental groups: placebo and propolis. Treatment: administration (2-4 times/day) of propolis or placebo spray for five days.
Participants will be assessed at day three and day five and referred to further treatment if their condition requires it. After 15 days there will be a final assessment.
What are the possible benefits and risks of participating?
Participants taking part in this study should have a benefit on the first symptoms of mild uncomplicated upper respiratory tract infections, including a reduction in the incidence of drug treatment and a reduction in the incidence of the emergence of antibiotic-resistant pathogenic strains. There are no known risks to participants taking part in this study, considering the traditional use of propolis for the maintenance of the oral cavity and upper respiratory tract health.
Where is the study run from?
U.C.C.P (Center for primary care), Benevento (Italy)
When is the study starting and how long is it expected to run for?
December 2019 to January 2020
Who is funding the study?
B Natural (Italy)
Who is the main contact?
Prof. Maria Daglia (scientific), maria.daglia@unina.it
Dr Cristina Esposito (public), cristina.esposito@unina.it
Contact information
Scientific
Università degli Studi di Napoli Federico II
Domenico Montesano street, 49
Naples
80131
Italy
 ORCID ID |
0000-0002-4870-7713 |
|---|---|
| Phone | +39 3331703492 |
| maria.daglia@unina.it |
Public
Università degli Studi di Napoli Federico II
Domenico Montesano street, 49
Naples
80131
Italy
| Phone | +39 (0)81678644 |
|---|---|
| cristina.esposito@unina.it |
Study information
| Study design | Interventional double-blind placebo-controlled randomized parallel single-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | 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 |
| Study acronym | DPRO |
| Study hypothesis | The clinical study purpose is to test the propolis extract capacity: 1. To reduce the first common symptoms occurring during mild uncomplicated URTIs and therefore the pharmacological treatment incidence (use of anti-inflammatory and/or antibiotic and/or antitussive drugs) 2. To reduce antibiotic-resistant pathogenic strains incidence at the end of the follow-up, in the subjects in which URTIs is caused by bacteria |
| Ethics approval(s) | Approved 18/12/2019, ASL Benevento Ethics Committee (Via Oderisio, n1, 82100, Benevento, Italy; +39 (0)824308419; comitatoetico@aslbenevento1.it), ref: 152869 |
| Condition | Uncomplicated mild upper respiratory tract infections |
| 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). |
| Intervention type | Supplement |
| Primary outcome measure | 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 measures | 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 |
| Overall study start date | 02/09/2019 |
| Overall study end date | 20/01/2020 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 122 |
| Total final enrolment | 122 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 19/12/2019 |
| Recruitment end date | 31/12/2019 |
Locations
Countries of recruitment
- Italy
Study participating centre
San Giorgio del Sannio
82100
Italy
Sponsor information
Industry
Via Gran Sasso, 33
Corbetta (MI)
20011
Italy
| Phone | +39 (0)249470332 |
|---|---|
| bnatural@bnatural.it | |
| Website | https://bnatural.it/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 15/04/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-review journal. |
| IPD sharing plan | Data of individual patients will be available upon request of patient permission. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 26/03/2020 | 27/03/2020 | No | No | |
| Results article | results | 08/10/2020 | 19/11/2020 | Yes | No |
Additional files
- ISRCTN17594930_PROTOCOL_26Mar2020.pdf
- uploaded 27/03/2020
Editorial Notes
19/11/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
05/08/2020: The following changes were made to the trial record:
1. The inclusion criteria were changed.
2. The plain English summary was updated to reflect these changes.
27/03/2020: Uploaded protocol (not peer reviewed) as an additional file.
26/03/2020: Trial’s existence confirmed by Università degli Studi di Napoli Federico II.
