Open, Randomised, Controlled Study to Evaluate the Role of a Dietary Supplement Containing <i>Pelargonium sidoides</i> Extract, Honey, Propolis, and Zinc as Adjuvant Treatment in Children with Acute Tonsillopharyngitis
Background/Objectives: A common reason for a pediatrician’s visit is acute tonsillopharyngitis (ATR), which is usually caused by viruses. A dietary supplement comprising <i>Pelargonium sidoides</i> extract, honey, propolis, and zinc was proposed as an effective adjuvant for the managemen...
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MDPI AG
2025-03-01
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| Online Access: | https://www.mdpi.com/2227-9067/12/3/345 |
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| author | Fabio Cardinale Dionisio Franco Barattini Alessandro Centi Greta Giuntini Maria Morariu Bordea Dorina Herteg Luca Barattini Cristian Radu Matei |
| author_facet | Fabio Cardinale Dionisio Franco Barattini Alessandro Centi Greta Giuntini Maria Morariu Bordea Dorina Herteg Luca Barattini Cristian Radu Matei |
| author_sort | Fabio Cardinale |
| collection | DOAJ |
| description | Background/Objectives: A common reason for a pediatrician’s visit is acute tonsillopharyngitis (ATR), which is usually caused by viruses. A dietary supplement comprising <i>Pelargonium sidoides</i> extract, honey, propolis, and zinc was proposed as an effective adjuvant for the management of respiratory tract infections. The study aimed to determine the efficacy of this dietary supplement in conjunction with standard of care (SoC) compared to SoC alone, in a pediatric population affected by ATR. Methods: This open randomized study (registered on ClinicalTrials.gov: NCT 04899401) involved three Romanian sites specialized in pediatric care. The primary endpoints were changes in Tonsillitis Severity Score and the number of patients failing to respond (evaluating the use of ibuprofen or high-dose paracetamol as a rescue medication). One hundred and thirty children, distributed into two groups, were enrolled and treated for six days. Results: The results showed an overall better performance in terms of efficacy of dietary supplement + SoC, compared to SoC alone, with lower total Tonsillitis Severity Score ratings on day 6 (<i>p</i> = 0.002) and lower sub-scores related to erythema and throat pain on day 6. No adverse events were reported. Investigators found compliance to be optimal. Conclusions: The administration of the dietary supplement + SoC in pediatric patients with ATR was found to be safe and superior to the administration of SoC alone in terms of efficacy. The results confirmed that the tested dietary supplement is an optimum effective adjuvant in the treatment of respiratory tract infections and is suitable for the daily clinical practice of pediatricians. |
| format | Article |
| id | doaj-art-983e3e922c3a40108c76fe61e9ffca43 |
| institution | OA Journals |
| issn | 2227-9067 |
| language | English |
| publishDate | 2025-03-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Children |
| spelling | doaj-art-983e3e922c3a40108c76fe61e9ffca432025-08-20T02:11:25ZengMDPI AGChildren2227-90672025-03-0112334510.3390/children12030345Open, Randomised, Controlled Study to Evaluate the Role of a Dietary Supplement Containing <i>Pelargonium sidoides</i> Extract, Honey, Propolis, and Zinc as Adjuvant Treatment in Children with Acute TonsillopharyngitisFabio Cardinale0Dionisio Franco Barattini1Alessandro Centi2Greta Giuntini3Maria Morariu Bordea4Dorina Herteg5Luca Barattini6Cristian Radu Matei7AOU “Policlinico-Giovanni XXIII”, Ospedale Pediatrico Giovanni XXIII—Università di Bari, 70126 Bari, ItalyOpera CRO, a TIGERMED Group Company, 300209 Timisoara, RomaniaPediatrica Srl, 57121 Livorno, ItalyPediatrica Srl, 57121 Livorno, ItalyCMMF Dr. Morariu Bordea, 300425 Timisoara, RomaniaCM Dr. Herteg, 300254 Timisoara, RomaniaTIGERMED Italy, Corso Buenos Aires, 6, 16129 Genova, ItalyCM Dr. Matei, Otelu Rosu, 325700 Caras-Severin, RomaniaBackground/Objectives: A common reason for a pediatrician’s visit is acute tonsillopharyngitis (ATR), which is usually caused by viruses. A dietary supplement comprising <i>Pelargonium sidoides</i> extract, honey, propolis, and zinc was proposed as an effective adjuvant for the management of respiratory tract infections. The study aimed to determine the efficacy of this dietary supplement in conjunction with standard of care (SoC) compared to SoC alone, in a pediatric population affected by ATR. Methods: This open randomized study (registered on ClinicalTrials.gov: NCT 04899401) involved three Romanian sites specialized in pediatric care. The primary endpoints were changes in Tonsillitis Severity Score and the number of patients failing to respond (evaluating the use of ibuprofen or high-dose paracetamol as a rescue medication). One hundred and thirty children, distributed into two groups, were enrolled and treated for six days. Results: The results showed an overall better performance in terms of efficacy of dietary supplement + SoC, compared to SoC alone, with lower total Tonsillitis Severity Score ratings on day 6 (<i>p</i> = 0.002) and lower sub-scores related to erythema and throat pain on day 6. No adverse events were reported. Investigators found compliance to be optimal. Conclusions: The administration of the dietary supplement + SoC in pediatric patients with ATR was found to be safe and superior to the administration of SoC alone in terms of efficacy. The results confirmed that the tested dietary supplement is an optimum effective adjuvant in the treatment of respiratory tract infections and is suitable for the daily clinical practice of pediatricians.https://www.mdpi.com/2227-9067/12/3/345dietary supplementstonsillitis<i>Pelargonium sidoides</i>honeypropoliszinc |
| spellingShingle | Fabio Cardinale Dionisio Franco Barattini Alessandro Centi Greta Giuntini Maria Morariu Bordea Dorina Herteg Luca Barattini Cristian Radu Matei Open, Randomised, Controlled Study to Evaluate the Role of a Dietary Supplement Containing <i>Pelargonium sidoides</i> Extract, Honey, Propolis, and Zinc as Adjuvant Treatment in Children with Acute Tonsillopharyngitis Children dietary supplements tonsillitis <i>Pelargonium sidoides</i> honey propolis zinc |
| title | Open, Randomised, Controlled Study to Evaluate the Role of a Dietary Supplement Containing <i>Pelargonium sidoides</i> Extract, Honey, Propolis, and Zinc as Adjuvant Treatment in Children with Acute Tonsillopharyngitis |
| title_full | Open, Randomised, Controlled Study to Evaluate the Role of a Dietary Supplement Containing <i>Pelargonium sidoides</i> Extract, Honey, Propolis, and Zinc as Adjuvant Treatment in Children with Acute Tonsillopharyngitis |
| title_fullStr | Open, Randomised, Controlled Study to Evaluate the Role of a Dietary Supplement Containing <i>Pelargonium sidoides</i> Extract, Honey, Propolis, and Zinc as Adjuvant Treatment in Children with Acute Tonsillopharyngitis |
| title_full_unstemmed | Open, Randomised, Controlled Study to Evaluate the Role of a Dietary Supplement Containing <i>Pelargonium sidoides</i> Extract, Honey, Propolis, and Zinc as Adjuvant Treatment in Children with Acute Tonsillopharyngitis |
| title_short | Open, Randomised, Controlled Study to Evaluate the Role of a Dietary Supplement Containing <i>Pelargonium sidoides</i> Extract, Honey, Propolis, and Zinc as Adjuvant Treatment in Children with Acute Tonsillopharyngitis |
| title_sort | open randomised controlled study to evaluate the role of a dietary supplement containing i pelargonium sidoides i extract honey propolis and zinc as adjuvant treatment in children with acute tonsillopharyngitis |
| topic | dietary supplements tonsillitis <i>Pelargonium sidoides</i> honey propolis zinc |
| url | https://www.mdpi.com/2227-9067/12/3/345 |
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