Clinical Evaluation of the AP203 Plant Extract Mixture in Adult Patients With Increased Incidence⦠(NCT06020001) | Clinical Trial Compass
CompletedNot Applicable
Clinical Evaluation of the AP203 Plant Extract Mixture in Adult Patients With Increased Incidence of Viral and/or Bacterial Upper Respiratory Tract Infections
Poland60 participantsStarted 2022-10-14
Plain-language summary
The aim of the study was to assess the efficacy and safety of AP203 preparation (RESCOVINĀ®) in a group of patients with increased incidence to viral and/or bacterial upper respiratory tract infections.
Who can participate
Age range18 Years ā 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;