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

NCT06020001 | Completed

• 1 other identifier: 06-AP-COV
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Upper Respiratory Tract Infection Bacterial

Keywords

Upper Respiratory Tract Infections; Bacterial Infections; Viral Infections; RESCOVIN; Plant extract; Chokeberry extract; Echinacea extract

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• hsCRP level

  Baseline, 2 months, 4 months, 6 months

• 8-iso-PGF2IsoP level

  Baseline, 2 months, 4 months, 6 months

• Cold Intensity Score

  Baseline, 2 months, 4 months, 6 months

Study Arms (3)

AP203 mixture (RESCOVIN®) in capsule form

EXPERIMENTAL

Patients with an increased incidence of upper respiratory tract infection

Dietary Supplement: AP203 mixture (RESCOVIN®)

AP203 mixture (RESCOVIN®) in syrup form

EXPERIMENTAL

Patients with an increased incidence of upper respiratory tract infection

Dietary Supplement: AP203 mixture (RESCOVIN®)

Placebo

PLACEBO COMPARATOR

Patients with an increased incidence of upper respiratory tract infection

Other: Placebo

Interventions

AP203 mixture (RESCOVIN®) DIETARY_SUPPLEMENT

Polyphenol-rich plant extracts Twice a day

AP203 mixture (RESCOVIN®) in capsule form

Placebo OTHER

Twice a day

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• AronPharma Sp. z o. o.: lead

Study Sites (1)

Pomorskie Centrum Reumatologiczne im. dr Jadwigi Titz-Kosko

Sopot, 81-820, Poland

Location

Related Publications (1)

• Zima K, Sochocka M, Ochnik M, Khaidakov B, Lemke K, Kowalczyk P. Therapeutic Potential of a Natural Blend of Aronia melancarpa, Lonicera caerulea, and Echinacea purpurea Extracts in Treating Upper Respiratory Tract Infections: Preliminary Clinical and In Vitro Immunomodulatory Insights. Int J Mol Sci. 2024 Dec 15;25(24):13436. doi: 10.3390/ijms252413436.

  PMID: 39769201 DERIVED

MeSH Terms

Conditions

Respiratory Tract Infections; Bacterial Infections; Virus Diseases

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Bacterial Infections and Mycoses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: August 31, 2023
• Study Start: October 14, 2022
• Primary Completion: April 27, 2023
• Study Completion: April 27, 2023
• Last Updated: September 11, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)