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Completed

NCT Number: NCT06020001

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pomorskie Centrum Reumatologiczne im. dr Jadwigi Titz-Kosko

Sopot, 81-820, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

AP203 mixture (RESCOVIN®)

Dietary Supplement

Polyphenol-rich plant extracts Twice a day

Placebo

Other

Twice a day

Primary outcomes

  1. Efficacy and safety of AP203

    Time frame: 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 outcomes

  1. hsCRP level

    Time frame: Baseline, 2 months, 4 months, 6 months

    Comparison of hsCRP level

  2. 8-iso-PGF2IsoP level

    Time frame: Baseline, 2 months, 4 months, 6 months

    Comparison of 8-iso-PGF2IsoP level

  3. Cold Intensity Score

    Time frame: Baseline, 2 months, 4 months, 6 months

    Comparison of Cold Intensity Score (CIS) values

Sponsors and collaborators

Lead sponsor

AronPharma Sp. z o. o.

Industry

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 31, 2023
Registry last updated
Sep 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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