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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

Primary Purpose

Upper Respiratory Tract Infection Bacterial

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
AP203 mixture (RESCOVIN®)
AP203 mixture (RESCOVIN®)
Placebo
Sponsored by
AronPharma Sp. z o. o.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Upper Respiratory Tract Infection Bacterial focused on measuring Upper Respiratory Tract Infections, Bacterial Infections, Viral Infections, RESCOVIN, Plant extract, Chokeberry extract, Echinacea extract

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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;

Sites / Locations

  • Pomorskie Centrum Reumatologiczne im. dr Jadwigi Titz-Kosko

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

AP203 mixture (RESCOVIN®) in capsule form

AP203 mixture (RESCOVIN®) in syrup form

Placebo

Arm Description

Patients with an increased incidence of upper respiratory tract infection

Patients with an increased incidence of upper respiratory tract infection

Patients with an increased incidence of upper respiratory tract infection

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

hsCRP level
Comparison of hsCRP level
8-iso-PGF2IsoP level
Comparison of 8-iso-PGF2IsoP level
Cold Intensity Score
Comparison of Cold Intensity Score (CIS) values

Full Information

First Posted
August 25, 2023
Last Updated
September 7, 2023
Sponsor
AronPharma Sp. z o. o.
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1. Study Identification

Unique Protocol Identification Number
NCT06020001
Brief Title
Clinical Evaluation of the AP203 Plant Extract Mixture in Adult Patients With Increased Incidence of Viral and/or Bacterial Upper Respiratory Tract Infections
Official Title
Clinical Evaluation of the AP203 Plant Extract Mixture in Adult Patients With Increased Incidence of Viral and/or Bacterial Upper Respiratory Tract Infections
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 14, 2022 (Actual)
Primary Completion Date
April 27, 2023 (Actual)
Study Completion Date
April 27, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AronPharma Sp. z o. o.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Respiratory Tract Infection Bacterial
Keywords
Upper Respiratory Tract Infections, Bacterial Infections, Viral Infections, RESCOVIN, Plant extract, Chokeberry extract, Echinacea extract

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AP203 mixture (RESCOVIN®) in capsule form
Arm Type
Experimental
Arm Description
Patients with an increased incidence of upper respiratory tract infection
Arm Title
AP203 mixture (RESCOVIN®) in syrup form
Arm Type
Experimental
Arm Description
Patients with an increased incidence of upper respiratory tract infection
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients with an increased incidence of upper respiratory tract infection
Intervention Type
Dietary Supplement
Intervention Name(s)
AP203 mixture (RESCOVIN®)
Intervention Description
Polyphenol-rich plant extracts Twice a day
Intervention Type
Dietary Supplement
Intervention Name(s)
AP203 mixture (RESCOVIN®)
Intervention Description
Polyphenol-rich plant extracts Twice a day
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Twice a day
Primary Outcome Measure Information:
Title
Efficacy and safety of AP203
Description
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.
Time Frame
Baseline, 2 months, 4 months, 6 months
Secondary Outcome Measure Information:
Title
hsCRP level
Description
Comparison of hsCRP level
Time Frame
Baseline, 2 months, 4 months, 6 months
Title
8-iso-PGF2IsoP level
Description
Comparison of 8-iso-PGF2IsoP level
Time Frame
Baseline, 2 months, 4 months, 6 months
Title
Cold Intensity Score
Description
Comparison of Cold Intensity Score (CIS) values
Time Frame
Baseline, 2 months, 4 months, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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;
Facility Information:
Facility Name
Pomorskie Centrum Reumatologiczne im. dr Jadwigi Titz-Kosko
City
Sopot
ZIP/Postal Code
81-820
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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