Status:
COMPLETED
Clinical Evaluation of the AP203 Plant Extract Mixture in Adult Patients With Increased Incidence of Viral and/or Bacterial Upper Respiratory Tract Infections
Lead Sponsor:
AronPharma Sp. z o. o.
Conditions:
Upper Respiratory Tract Infection Bacterial
Eligibility:
All Genders
18-70 years
Phase:
NA
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...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
October 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 27 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06020001
Start Date
October 14 2022
End Date
April 27 2023
Last Update
September 11 2023
Active Locations (1)
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1
Pomorskie Centrum Reumatologiczne im. dr Jadwigi Titz-Kosko
Sopot, Poland, 81-820