Clinical trial NCT06020001: Clinical Evaluation of the AP203 Plant Extract Mixture in Adult Patients With Increased Incidence of Viral and/or Bacterial Upper Respiratory Tract Infections
Official title: Clinical Evaluation of the AP203 Plant Extract Mixture in Adult Patients With Increased Incidence of Viral and/or Bacterial Upper Respiratory Tract Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Respiratory Tract Infection Bacterial
Keywords: Upper Respiratory Tract Infections
Bacterial Infections
Viral Infections
RESCOVIN
Plant extract
Chokeberry extract
Echinacea extract
Lead sponsor: AronPharma Sp. z o. o.
Sponsor class: INDUSTRY
First posted: 2023-08-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Efficacy and safety of AP203
timeFrame: Baseline, 2 months, 4 months, 6 months
Secondary outcomes:
measure: hsCRP level
timeFrame: Baseline, 2 months, 4 months, 6 months
measure: 8-iso-PGF2IsoP level
timeFrame: Baseline, 2 months, 4 months, 6 months
measure: Cold Intensity Score
timeFrame: Baseline, 2 months, 4 months, 6 months
Other outcomes:
Locations:
city: Sopot
country: Poland
facility: Pomorskie Centrum Reumatologiczne im. dr Jadwigi Titz-Kosko
Study officials:
References: