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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-14

Study Completion Date

2023-04-27

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Upper Respiratory Tract Infection Bacterial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AP203 mixture (RESCOVIN®) in capsule form

Patients with an increased incidence of upper respiratory tract infection

Group Type EXPERIMENTAL

AP203 mixture (RESCOVIN®)

Intervention Type DIETARY_SUPPLEMENT

Polyphenol-rich plant extracts Twice a day

AP203 mixture (RESCOVIN®) in syrup form

Patients with an increased incidence of upper respiratory tract infection

Group Type EXPERIMENTAL

AP203 mixture (RESCOVIN®)

Intervention Type DIETARY_SUPPLEMENT

Polyphenol-rich plant extracts Twice a day

Placebo

Patients with an increased incidence of upper respiratory tract infection

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Twice a day

Interventions

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AP203 mixture (RESCOVIN®)

Polyphenol-rich plant extracts Twice a day

Intervention Type DIETARY_SUPPLEMENT

AP203 mixture (RESCOVIN®)

Polyphenol-rich plant extracts Twice a day

Intervention Type DIETARY_SUPPLEMENT

Placebo

Twice a day

Intervention Type OTHER

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes