Upper Respiratory Tract Infection Bacterial
Conditions
Keywords
Upper Respiratory Tract Infections, Bacterial Infections, Viral Infections, RESCOVIN, Plant extract, Chokeberry extract, Echinacea extract
Brief summary
The aim of the study was to assess the efficacy and safety of AP203 preparation (RESCOVIN®) in a group of patients with increased incidence to viral and/or bacterial upper respiratory tract infections.
Detailed description
Randomized, double-blind, cross over study conducted under medical supervision on 1) group of 30 patients receiving AP203 mixture in capsule form and 2) group of 30 receiving placebo. After a washout period a group receiving placebo receiver AP203 mixture in syrup form. The study group was adult patients with an increased incidence of upper respiratory tract infection. During the study, the effect of a mixture of AP203 extracts (RESCOVIN®) on markers of inflammation and oxidative stress and the effect on the incidence of upper respiratory tract infections was assessed.
Interventions
DIETARY_SUPPLEMENTAP203 mixture (RESCOVIN®)
Polyphenol-rich plant extracts Twice a day
OTHERPlacebo
Twice a day
Sponsors
AronPharma Sp. z o. o.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Women and men, 18-70 years old * Healthy patients at the time of enrollment to the study (without active upper respiratory tract infection) * Presence of 2 or more episodes of upper respiratory tract infections or \>=2 episodes of cold during the year * Patients with chronic upper respiratory tract diseases including bronchial asthma * Signed informed consent * Women: contraception or postmenopausal age
Exclusion criteria
* Intake of supplements containing plant extracts, polyphenols or anthocyanins for the 3 months prior to the study initiation * Acute inflammation * Oral immunosuppressive drugs * Steroid, anti-allergic drugs in exacerbations of chronic disease at least 2 months from the start of study participation * Antibiotic therapy 1 month prior to study initiation * Participation in another clinical trial; * Oncological disease, autoimmune disease, severe liver dysfunction, tuberculosis, leukaemia, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplantation; * Hypersensitivity/allergy to any of the ingredients of the product, allergy to plants of the Asteraceae family (e.g. chamomile, calendula); * Women who are pregnant or planning to become pregnant during the study period;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy and safety of AP203 | Baseline, 2 months, 4 months, 6 months | Clinical evaluation of the efficacy and safety of AP203, in a group of patients with an increased incidence of viral and/or bacterial upper respiratory tract infections. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hsCRP level | Baseline, 2 months, 4 months, 6 months | Comparison of hsCRP level |
| 8-iso-PGF2IsoP level | Baseline, 2 months, 4 months, 6 months | Comparison of 8-iso-PGF2IsoP level |
| Cold Intensity Score | Baseline, 2 months, 4 months, 6 months | Comparison of Cold Intensity Score (CIS) values |
Countries
Poland
Outcome results
None listed