Clinical Evaluation of the AP203 Plant Extract Mixture in Adult Patients With Increased Incidence of Viral and/or Bacterial Upper Respiratory Tract Infections

Not Applicable

Completed

• Conditions: Upper Respiratory Tract Infection Bacterial
• Interventions: Dietary Supplement: AP203 mixture (RESCOVIN®); Other: Placebo

• Registration Number: NCT06020001
• Lead Sponsor: AronPharma Sp. z o. o.

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.

Study Timeline

• Study Start: 2022-10-14
• Primary Completion: 2023-04-27
• Study Completion: 2023-04-27
• Study First Submitted: 2023-08-25
• Study First Submitted QC: 2023-08-25
• Study First Posted: 2023-08-31
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-07
• Last Update Posted: 2023-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AP203 mixture (RESCOVIN®) in capsule form	AP203 mixture (RESCOVIN®)	Patients with an increased incidence of upper respiratory tract infection
AP203 mixture (RESCOVIN®) in syrup form	AP203 mixture (RESCOVIN®)	Patients with an increased incidence of upper respiratory tract infection
Placebo	Placebo	Patients with an increased incidence of upper respiratory tract infection

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
8-iso-PGF2IsoP level	Baseline, 2 months, 4 months, 6 months	Comparison of 8-iso-PGF2IsoP level
hsCRP level	Baseline, 2 months, 4 months, 6 months	Comparison of hsCRP level
Cold Intensity Score	Baseline, 2 months, 4 months, 6 months	Comparison of Cold Intensity Score (CIS) values

Trial Locations

Locations (1)

Pomorskie Centrum Reumatologiczne im. dr Jadwigi Titz-Kosko; 🇵🇱 Sopot, Poland