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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Upper Respiratory Tract Infection Bacterial

Intervention / Treatment
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* Dietary Supplement: AP203 mixture (RESCOVIN®)
* Dietary Supplement: AP203 mixture (RESCOVIN®)
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AP203 mixture (RESCOVIN®) in capsule form<br>Patients with an increased incidence of upper respiratory tract infection | Dietary Supplement: AP203 mixture (RESCOVIN®)<br>* Polyphenol-rich plant extracts Twice a day<br>|
| Experimental: AP203 mixture (RESCOVIN®) in syrup form<br>Patients with an increased incidence of upper respiratory tract infection | Dietary Supplement: AP203 mixture (RESCOVIN®)<br>* Polyphenol-rich plant extracts Twice a day<br>|
| Placebo Comparator: Placebo<br>Patients with an increased incidence of upper respiratory tract infection | Other: Placebo<br>* Twice a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hsCRP level | Comparison of hsCRP level | Baseline, 2 months, 4 months, 6 months | 
| 8-iso-PGF2IsoP level | Comparison of 8-iso-PGF2IsoP level | Baseline, 2 months, 4 months, 6 months | 
| Cold Intensity Score | Comparison of Cold Intensity Score (CIS) values | Baseline, 2 months, 4 months, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Plant extract, Upper Respiratory Tract Infections, Bacterial Infections, Viral Infections, RESCOVIN, Chokeberry extract, Echinacea extract