TonsillopharyngitisNCT04899401
Trial To Assess Efficacy and Safety of PediaFlu® in Children With Acute Tonsillopharyngitis / Rhinopharyngitis
A study of Tonsillopharyngitis and Rhinopharyngitis, run by Pediatrica S.r.l at 3 sites in Romania.
Trial summary
Sore throat or acute tonsillopharyngitis, often referred to as angina catarrhalis in Central and Eastern Europe, affects mainly children, adolescents and young adults and represents one of the most common reasons to consult a family physician. Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Tonsillopharyngitis, Rhinopharyngitis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 3 sitesRomania
- Study dates
- 3 Jun 2021to 12 Aug 2021
- 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 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients will be eligible for inclusion if all the following criteria are respected:
- male and female (children 3 - 10 years old);
- acute tonsillitis / rhinopharyngitis (sore throat, catarrhal angina), duration of complaints ≤ 48 hours,
- Absence of pharyngeal exudate and/or Mc Isaac score 0-1 + negative rapid test for β-hemolytic streptococcus and SARS-CoV-2 identification
- tonsillitis symptoms score (TSS) ≥ 8 points,
- both parents capable of and freely willing to provide written informed consent prior to participating in the clinical investigation.
- for children above 6 years old capable willing to provide written informed consent prior to participating in the clinical investigation.
Who cannot join
- evidence of lacunar or follicular angina.
- more than two episodes of tonsillitis within the last 12 months,
- mandatory indication for therapy with antibiotics (e.g., abscess, septic tonsillitis, history of rheumatic fever, post-streptococcus glomerulonephritis, and chorea minor Sydenham),
- history of close contact with SARS-COV-2 infected individuals in the last 10 days before symptoms onset
- treatment with antibiotics within 4 months prior to study inclusion,
- increased hemorrhagic diathesis, chronic diseases (e.g. severe heart, kidney or liver diseases), immunosuppression,
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- known or suspected hypersensitivity to study medication,
- concomitant treatment potentially influencing study outcome or known interactions with study medication (e.g., coumarin derivatives),
- participation in another clinical study within the last 3 months prior to clinical investigation inclusion.
Trial locations and contacts
3 sites in 1 country.
Romania3 sites
CMMF Dr. Morariu Bordea Maria
Timișoara, Timiș County, 300210
CM Dr. Herteg Dorina
Timișoara, Timiș County, 300288
CM Dr. Matei Cristian-Radu
Timișoara
About this study
Official title: A Randomized, Open, Controlled Study to Evaluate the Efficacy and Safety of PediaFlù® (Dietary Supplement) Along With Standard of Care in Children With Acute Tonsillopharyngitis / Rhinopharyngitis Versus Standard of Care Only
Sore throat or acute tonsillopharyngitis, often referred to as angina catarrhalis in Central and Eastern Europe, affects mainly children, adolescents and young adults and represents one of the most common reasons to consult a family physician. While most patients complaining of sore throats have an infection, it has been estimated that fewer than 20% present with a clear indication for antibiotic therapy, i.e., are positive for hemolytic streptococcus.
Acute tonsillopharyngitis (ATP) is a highly prevalent, seasonal infective disorder characterized by an inflammation of the pharynx and the palatine tonsils, which occurs in all age groups and accounts for about 5% of all visits in pediatric care. Common symptoms of ATP include sore throat, dysphagia, red pharynx, enlarged tonsils sometimes covered with exudate, fever with sudden onset, malaise, gastrointestinal complaints, halitosis, rhinorrhea and cough. Children with non-streptococcal tonsillopharyngitis are often over-treated with antibiotics.
Read more
The scientific literature currently available shows that the extract of Pelargonium sidoides may be effective in the treatment of disorders affecting the respiratory tract.
Evidence shows that zinc is beneficial for the common cold in healthy children and adults living in high-income countries and it may inhibit replication of the virus. In addition, zinc (lozenges or syrup) reduces the average duration of the common cold in healthy people assuming zinc within 24 hours of onset of symptoms Propolis has been widely investigated for its antibacterial, antiviral, and anti-inflammatory properties and is administered as an add-on therapy during watchful waiting for better control of symptoms in non-streptococcal pharyngitis.
The above-mentioned considerations, have suggested Pediatrica Srl to develop a food supplement specific for pediatric age for the well-being of the airways (PediaFlù®). This product is actually on the market as adjuvant in seasonal diseases.
The present clinical investigation is planned to verify and confirm these encouraging results in a setting of standard clinical practice.
This is a randomized, open, controlled study to evaluate the efficacy and safety of PediaFlù® (dietary supplement) along with standard of care in children with acute tonsillopharyngitis / rhinopharyngitis versus standard of care only.
The primary objective is to evaluate the efficacy and safety of the tested dietary supplement administered along with standard care vs standard care alone in children affected by acute tonsillopharyngitis (ATP).
The secondary objectives of the study are the assessment of the use of rescue medicine (Ibuprofen or high dose of Paracetamol) and the evaluation of the overall improvement symptoms.
- Conditions
- Tonsillopharyngitis, Rhinopharyngitis
- Being tested
- Standard of care + PediaFlù®, Standard of care
- Keywords
- ATP, tonsillopharyngitis, Rhinopharyngitis, PediaFlù®, Pelargonium sidoides, Propolis
- Medical subject headings
- Nasopharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of care + PediaFlù®Dietary supplement
Standard of care: Standard of care for acute tonsillitis / rhinopharyngitis is focused on symptomatic treatment. PediaFlù®: During the 6 days of the clinical investigation, the subjects will administer PediaFlù® 5ml x3 times per day for children below 6 years and 10mlx3 times per day for children above 6 years.
Standard of careOther
Standard of care for acute tonsillitis / rhinopharyngitis is focused on symptomatic treatment. Standard of care Nasopharyngeal liberation through hydration with drinking fluids to support body fluid excretion, aspiration of secretions, NaCl solution for nasal irrigation, Nasal sprays with sea water, nasal spray with active compound (to be used only at special indication of the medical doctor) Throat spray with Benzydamine hydrochloride (Tantum Verde®), Pediatric use: children over 6 and below 12: 4 sprays 2 - 6 times a day. Children (under 6 years): 1 spray per 4 kg of body weight, a maximum of 4 sprays at once, 2-6 times a day according to the leaflet. Each spray equals 0.17 ml of solution. Acetaminophen (Paracetamol) per os: at need, as antipyretic (>38,5C), 10 mg/kg/dose, per need every 6-8 hours or according to the leaflet, maximum dosage 80 mg / kg / day. A dosage of over 30 mg/Kg/dose will result in an IP failure;
| Study group | Role | What they receive |
|---|---|---|
| Standard of care +PediaFlù® | Experimental | Not described Receives: Dietary Supplement: Standard of care + PediaFlù® |
| Standard of care | Active comparator | Not described Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tonsillitis severity score
Tonsillitis severity score (TSS) Intensity score in between 0 and 3. The results will be compared in terms of absolute change of tonsillitis severity score from baseline to final visit, between groups and intra-groups;
Measured: 6 days
Number of treatment failure
The result of using rescue medicine (Ibuprofen or dosage of over 30 mg/Kg/dose daily of paracetamol) will be compared in the two groups.
Measured: 6 days
AE/SAE incidence.
Adverse Events/Serious Adverse Events incidence.
Measured: 6 days
Secondary outcomes (2)
Compliance
IP compliance (the amount of IP ingested divided by the value the subject should have ingested and multiplied by 100);
Measured: 6 days
Symptoms improvement
Overall symptoms improvement through IGAE (Investigator Global Assessment of Efficacy), a 4-point scale: 1= very good efficacy, 2 = good efficacy, 3 = moderate efficacy and 4 = poor efficacy.
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start3 Jun 2021
- Primary completion12 Aug 2021
- Study completion12 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TonsillopharyngitisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, open-label, multicenter clinical investigation, with two parallel groups of subjects.
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pediatrica S.r.l
- Sponsor type
- University, hospital or other
- Collaborators
- Opera CRO, a TIGERMED Group Company
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04899401
- Sponsor's protocol ID
- OPPED/0120/FS
- Status last verified
- Jun 2021
- First submitted
- 19 May 2021
- Last updated
- 8 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cardinale F, Barattini DF, Centi A, Giuntini G, Bordea MM, Herteg D, Barattini L, Matei CR. Open, Randomised, Controlled Study to Evaluate the Role of a Dietary Supplement Containing Pelargonium sidoides Extract, Honey, Propolis, and Zinc as Adjuvant Treatment in Children with Acute Tonsillopharyngitis. Children (Basel). 2025 Mar 10;12(3):345. doi: 10.3390/children12030345.
PubMed 40150627Cardinale F, Barattini DF, Sbrocca F, Centi A, Giuntini G, Morariu Bordea M, Herteg D, Rosu S, Matei CR. The Effects of a Dietary Supplement (PediaFlu) Plus Standard of Care in Children With Acute Tonsillopharyngitis/Rhinopharyngitis: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 May 31;13:e53703. doi: 10.2196/53703.
PubMed 38819917
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open, Controlled Study to Evaluate the Efficacy and Safety of PediaFlù® (Dietary Supplement) Along With Standard of Care in Children With Acute Tonsillopharyngitis / Rhinopharyngitis Versus Standard of Care Only
- ClinicalTrials.gov ID
- NCT04899401
- Acronym / sponsor ID
- OPPED/0120/FS
- Conditions
- Tonsillopharyngitis, Rhinopharyngitis
- Keywords
- ATP, tonsillopharyngitis, Rhinopharyngitis, PediaFlù®, Pelargonium sidoides, Propolis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Pediatrica S.r.lUniversity, hospital or other
- Collaborators
- Opera CRO, a TIGERMED Group Company
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- 12 Aug 2021 (actual)
- Study completion
- 12 Aug 2021 (actual)
- First posted
- 24 May 2021 (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.
Sore throat or acute tonsillopharyngitis, often referred to as angina catarrhalis in Central and Eastern Europe, affects mainly children, adolescents and young adults and represents one of the most common reasons to consult a family physician. While most patients complaining of sore throats have an infection, it has been estimated that fewer than 20% present with a clear indication for antibiotic therapy, i.e., are positive for hemolytic streptococcus.
Acute tonsillopharyngitis (ATP) is a highly prevalent, seasonal infective disorder characterized by an inflammation of the pharynx and the palatine tonsils, which occurs in all age groups and accounts for about 5% of all visits in pediatric care. Common symptoms of ATP include sore throat, dysphagia, red pharynx, enlarged tonsils sometimes covered with exudate, fever with sudden onset, malaise, gastrointestinal complaints, halitosis, rhinorrhea and cough. Children with non-streptococcal tonsillopharyngitis are often over-treated with antibiotics.
The scientific literature currently available shows that the extract of Pelargonium sidoides may be effective in the treatment of disorders affecting the respiratory tract.
Evidence shows that zinc is beneficial for the common cold in healthy children and adults living in high-income countries and it may inhibit replication of the virus. In addition, zinc (lozenges or syrup) reduces the average duration of the common cold in healthy people assuming zinc within 24 hours of onset of symptoms Propolis has been widely investigated for its antibacterial, antiviral, and anti-inflammatory properties and is administered as an add-on therapy during watchful waiting for better control of symptoms in non-streptococcal pharyngitis.
The above-mentioned considerations, have suggested Pediatrica Srl to develop a food supplement specific for pediatric age for the well-being of the airways (PediaFlù®). This product is actually on the market as adjuvant in seasonal diseases.
The present clinical investigation is planned to verify and confirm these encouraging results in a setting of standard clinical practice.
This is a randomized, open, controlled study to evaluate the efficacy and safety of PediaFlù® (dietary supplement) along with standard of care in children with acute tonsillopharyngitis / rhinopharyngitis versus standard of care only.
The primary objective is to evaluate the efficacy and safety of the tested dietary supplement administered along with standard care vs standard care alone in children affected by acute tonsillopharyngitis (ATP).
The secondary objectives of the study are the assessment of the use of rescue medicine (Ibuprofen or high dose of Paracetamol) and the evaluation of the overall improvement symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, open-label, multicenter clinical investigation, with two parallel groups of subjects.
| Arm | Type | Receives |
|---|---|---|
| Standard of care +PediaFlù® | Experimental | Dietary Supplement: Standard of care + PediaFlù® |
| Standard of care | Active comparator | Other: Standard of care |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Patients will be eligible for inclusion if all the following criteria are respected:
- male and female (children 3 - 10 years old);
- acute tonsillitis / rhinopharyngitis (sore throat, catarrhal angina), duration of complaints ≤ 48 hours,
- Absence of pharyngeal exudate and/or Mc Isaac score 0-1 + negative rapid test for β-hemolytic streptococcus and SARS-CoV-2 identification
- tonsillitis symptoms score (TSS) ≥ 8 points,
Key exclusion criteria (9 listed)
- evidence of lacunar or follicular angina.
- more than two episodes of tonsillitis within the last 12 months,
- mandatory indication for therapy with antibiotics (e.g., abscess, septic tonsillitis, history of rheumatic fever, post-streptococcus glomerulonephritis, and chorea minor Sydenham),
- history of close contact with SARS-COV-2 infected individuals in the last 10 days before symptoms onset
- treatment with antibiotics within 4 months prior to study inclusion,
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 |
|---|---|---|
| Standard of care + PediaFlù®Standard of care: Standard of care for acute tonsillitis / rhinopharyngitis is focused on symptomatic treatment. PediaFlù®: During the 6 days of the clinical investigation, the subjects will administer PediaFlù® 5ml x3 times per day for children below 6 years and 10mlx3 times per day for children above 6 years. | Dietary supplement | Standard of care +PediaFlù® |
| Standard of careStandard of care for acute tonsillitis / rhinopharyngitis is focused on symptomatic treatment. Standard of care Nasopharyngeal liberation through hydration with drinking fluids to support body fluid excretion, aspiration of secretions, NaCl solution for nasal irrigation, Nasal sprays with sea water, nasal spray with active compound (to be used only at special indication of the medical doctor) Throat spray with Benzydamine hydrochloride (Tantum Verde®), Pediatric use: children over 6 and below 12: 4 sprays 2 - 6 times a day. Children (under 6 years): 1 spray per 4 kg of body weight, a maximum of 4 sprays at once, 2-6 times a day according to the leaflet. Each spray equals 0.17 ml of solution. Acetaminophen (Paracetamol) per os: at need, as antipyretic (>38,5C), 10 mg/kg/dose, per need every 6-8 hours or according to the leaflet, maximum dosage 80 mg / kg / day. A dosage of over 30 mg/Kg/dose will result in an IP failure; | Other | Standard of care |
Primary outcome
Tonsillitis severity score
Time frame: 6 days
Tonsillitis severity score (TSS) Intensity score in between 0 and 3. The results will be compared in terms of absolute change of tonsillitis severity score from baseline to final visit, between groups and intra-groups;
Number of treatment failure
Time frame: 6 days
The result of using rescue medicine (Ibuprofen or dosage of over 30 mg/Kg/dose daily of paracetamol) will be compared in the two groups.
AE/SAE incidence.
Time frame: 6 days
Adverse Events/Serious Adverse Events incidence.
2 secondary outcomes
Compliance
Time frame: 6 days
Symptoms improvement
Time frame: 6 days
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 8 Sep 2021.
- Derived from this study: PubMed 40150627Cardinale F, Barattini DF, Centi A, Giuntini G, Bordea MM, Herteg D, Barattini L, Matei CR. Open, Randomised, Controlled Study to Evaluate the Role of a Dietary Supplement Containing Pelargonium sidoides Extract, Honey, Propolis, and Zinc as Adjuvant Treatment in Children with Acute Tonsillopharyngitis. Children (Basel). 2025 Mar 10;12(3):345. doi: 10.3390/children12030345.
- Derived from this study: PubMed 38819917Cardinale F, Barattini DF, Sbrocca F, Centi A, Giuntini G, Morariu Bordea M, Herteg D, Rosu S, Matei CR. The Effects of a Dietary Supplement (PediaFlu) Plus Standard of Care in Children With Acute Tonsillopharyngitis/Rhinopharyngitis: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 May 31;13:e53703. doi: 10.2196/53703.
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Tonsillopharyngitis and Rhinopharyngitis, run by Pediatrica S.r.l at 3 sites in Romania.
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 7 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 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Romania. 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. 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?
Tonsillitis severity score (time frame: 6 days). The study lists 3 primary outcomes in all. 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 NCT04899401, which also lists 2 linked publications.
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 8 Sep 2021.