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

Sponsor

AronPharma Sp. z o. o. (Industry)

Overall Status

Completed

CT.gov ID

NCT06020001

Collaborator

(none)

Enrollment

Location

Arms

6.4

Actual Duration (Months)

9.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Upper Respiratory Tract Infection Bacterial	Dietary Supplement: AP203 mixture (RESCOVIN®) Dietary Supplement: AP203 mixture (RESCOVIN®) Other: Placebo	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Oct 14, 2022

Actual Primary Completion Date :

Apr 27, 2023

Actual Study Completion Date :

Apr 27, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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;