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

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.

Study Overview

• Status: Completed
• Conditions: Upper Respiratory Tract Infection Bacterial
• Intervention / Treatment: Other: Placebo; Dietary supplement: AP203 mixture (RESCOVIN®)

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Sopot, Poland, 81-820
    • Pomorskie Centrum Reumatologiczne im. dr Jadwigi Titz-Kosko

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AP203 mixture (RESCOVIN®) in capsule form; Patients with an increased incidence of upper respiratory tract infection	Dietary supplement: AP203 mixture (RESCOVIN®); Polyphenol-rich plant extracts Twice a day
Experimental: AP203 mixture (RESCOVIN®) in syrup form; Patients with an increased incidence of upper respiratory tract infection	Dietary supplement: AP203 mixture (RESCOVIN®); Polyphenol-rich plant extracts Twice a day
Placebo Comparator: Placebo; Patients with an increased incidence of upper respiratory tract infection	Other: Placebo; Twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy and safety of AP203	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.	Baseline, 2 months, 4 months, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hsCRP level	Comparison of hsCRP level	Baseline, 2 months, 4 months, 6 months
8-iso-PGF2IsoP level	Comparison of 8-iso-PGF2IsoP level	Baseline, 2 months, 4 months, 6 months
Cold Intensity Score	Comparison of Cold Intensity Score (CIS) values	Baseline, 2 months, 4 months, 6 months

Collaborators and Investigators

• Sponsor: AronPharma Sp. z o. o.

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2022
• Primary Completion (Actual): April 27, 2023
• Study Completion (Actual): April 27, 2023

Study Registration Dates

• First Submitted: August 25, 2023
• First Submitted That Met QC Criteria: August 25, 2023
• First Posted (Actual): August 31, 2023

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Bacterial Infections; Plant extract; Upper Respiratory Tract Infections; Viral Infections; Chokeberry extract; RESCOVIN; Echinacea extract
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Respiratory Tract Infections; Bacterial Infections
• Other Study ID Numbers: 06-AP-COV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No