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

A

AronPharma

Status

Completed

Conditions

Upper Respiratory Tract Infection Bacterial

Treatments

Other: Placebo
Dietary Supplement: AP203 mixture (RESCOVIN®)

Study type

Interventional

Funder types

Industry

Identifiers

NCT06020001
06-AP-COV

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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;

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

60 participants in 3 patient groups, including a placebo group

AP203 mixture (RESCOVIN®) in capsule form
Experimental group
Description:
Patients with an increased incidence of upper respiratory tract infection
Treatment:
Dietary Supplement: AP203 mixture (RESCOVIN®)
Dietary Supplement: AP203 mixture (RESCOVIN®)
AP203 mixture (RESCOVIN®) in syrup form
Experimental group
Description:
Patients with an increased incidence of upper respiratory tract infection
Treatment:
Dietary Supplement: AP203 mixture (RESCOVIN®)
Dietary Supplement: AP203 mixture (RESCOVIN®)
Placebo
Placebo Comparator group
Description:
Patients with an increased incidence of upper respiratory tract infection
Treatment:
Other: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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