Upper Respiratory Tract Infection BacterialNCT06020001
Clinical Evaluation of the AP203 Plant Extract Mixture in Adult Patients With Increased Incidence of Viral and/or Bacterial Upper Respiratory Tract Infections
A study testing AP203 mixture (RESCOVIN®) in people with Upper Respiratory Tract Infection Bacterial, run by AronPharma Sp. z o. o. at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Respiratory Tract Infection Bacterial
- What is being tested?
- AP203 mixture (RESCOVIN®)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 14 Oct 2022to 27 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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 locations and contacts
1 site in 1 country.
Poland1 site
Pomorskie Centrum Reumatologiczne im. dr Jadwigi Titz-Kosko
Sopot, 81-820
About this study
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.
Read the 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.
- Being tested
- AP203 mixture (RESCOVIN®), Placebo
- Keywords
- Upper Respiratory Tract Infections, Bacterial Infections, Viral Infections, RESCOVIN, Plant extract, Chokeberry extract, Echinacea extract
- Medical subject headings
- Respiratory Tract Infections, Bacterial Infections, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AP203 mixture (RESCOVIN®)Dietary supplement
Polyphenol-rich plant extracts Twice a day
AP203 mixture (RESCOVIN®)Dietary supplement
Polyphenol-rich plant extracts Twice a day
PlaceboOther
Twice a day
| Study group | Role | What they receive |
|---|---|---|
| AP203 mixture (RESCOVIN®) in capsule form | Experimental | Patients with an increased incidence of upper respiratory tract infection Receives: Dietary Supplement: AP203 mixture (RESCOVIN®) |
| AP203 mixture (RESCOVIN®) in syrup form | Experimental | Patients with an increased incidence of upper respiratory tract infection Receives: Dietary Supplement: AP203 mixture (RESCOVIN®) |
| Placebo | Placebo comparator | Patients with an increased incidence of upper respiratory tract infection Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 2 months, 4 months, 6 months
Secondary outcomes (3)
hsCRP level
Comparison of hsCRP level
Measured: Baseline, 2 months, 4 months, 6 months
8-iso-PGF2IsoP level
Comparison of 8-iso-PGF2IsoP level
Measured: Baseline, 2 months, 4 months, 6 months
Cold Intensity Score
Comparison of Cold Intensity Score (CIS) values
Measured: Baseline, 2 months, 4 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start14 Oct 2022
- Primary completion27 Apr 2023
- Study completion27 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Upper Respiratory Tract Infection BacterialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- AronPharma Sp. z o. o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06020001
- Sponsor's protocol ID
- 06-AP-COV
- Status last verified
- Sep 2023
- First submitted
- 25 Aug 2023
- Last updated
- 11 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zima K, Sochocka M, Ochnik M, Khaidakov B, Lemke K, Kowalczyk P. Therapeutic Potential of a Natural Blend of Aronia melancarpa, Lonicera caerulea, and Echinacea purpurea Extracts in Treating Upper Respiratory Tract Infections: Preliminary Clinical and In Vitro Immunomodulatory Insights. Int J Mol Sci. 2024 Dec 15;25(24):13436. doi: 10.3390/ijms252413436.
PubMed 39769201
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06020001
- Acronym / sponsor ID
- 06-AP-COV
- Keywords
- Upper Respiratory Tract Infections, Bacterial Infections, Viral Infections, RESCOVIN, Plant extract, Chokeberry extract, Echinacea extract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- AronPharma Sp. z o. o.Industry (pharma, biotech, devices)
- Study start
- 14 Oct 2022 (actual)
- Primary completion
- 27 Apr 2023 (actual)
- Study completion
- 27 Apr 2023 (actual)
- First posted
- 31 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AP203 mixture (RESCOVIN®) in capsule form | Experimental | Dietary Supplement: AP203 mixture (RESCOVIN®)Patients with an increased incidence of upper respiratory tract infection |
| AP203 mixture (RESCOVIN®) in syrup form | Experimental | Dietary Supplement: AP203 mixture (RESCOVIN®)Patients with an increased incidence of upper respiratory tract infection |
| Placebo | Placebo comparator | Other: PlaceboPatients with an increased incidence of upper respiratory tract infection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AP203 mixture (RESCOVIN®)Polyphenol-rich plant extracts Twice a day | Dietary supplement | AP203 mixture (RESCOVIN®) in capsule form |
| AP203 mixture (RESCOVIN®)Polyphenol-rich plant extracts Twice a day | Dietary supplement | AP203 mixture (RESCOVIN®) in syrup form |
| PlaceboTwice a day | Other | Placebo |
Primary outcome
Efficacy and safety of AP203
Time frame: Baseline, 2 months, 4 months, 6 months
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.
3 secondary outcomes
hsCRP level
Time frame: Baseline, 2 months, 4 months, 6 months
8-iso-PGF2IsoP level
Time frame: Baseline, 2 months, 4 months, 6 months
Cold Intensity Score
Time frame: Baseline, 2 months, 4 months, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Derived from this study: PubMed 39769201Zima K, Sochocka M, Ochnik M, Khaidakov B, Lemke K, Kowalczyk P. Therapeutic Potential of a Natural Blend of Aronia melancarpa, Lonicera caerulea, and Echinacea purpurea Extracts in Treating Upper Respiratory Tract Infections: Preliminary Clinical and In Vitro Immunomodulatory Insights. Int J Mol Sci. 2024 Dec 15;25(24):13436. doi: 10.3390/ijms252413436.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AP203 mixture (RESCOVIN®) in people with Upper Respiratory Tract Infection Bacterial, run by AronPharma Sp. z o. o. at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy and safety of AP203 (time frame: Baseline, 2 months, 4 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06020001, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2023.