Clinical Evaluation of Azka Nasal and Throat, a Herbal Formulation, Versus Prospan in Pediatric Acute Nasopharyngitis: A Randomized Controlled Trial

Background: This study aimed to evaluate the efficacy and safety of Azka Nasal and Throat for children, an herbal formulation containing Bupleurum sinense, Platycodon grandiflorum, Scutellaria baicalensis, Codonopsis, and Hedera helix, compared with those of Prospan Cough Syrup (Hedera helix) in pediatric acute nasopharyngitis (ANP). Methods:A randomized, open-label, controlled trial was conducted on 24 children (aged 4-6 years) with ANP.Participants received Azka (n=12) or Prospan (n=12) for 7 days and monitored for 8 days.Outcomes included cough severity, frequency, phlegm status, and laboratory markers, with safety assessed by monitoring adverse events.Results: Both treatments had similar effects on laboratory parameters (white blood cell count, C-reactive protein, alanine transaminase, aspartate transaminase, and urea; p>0.05).In the Azka group, nighttime cough decreased from 3.00 at baseline to 1.50 on day 4, resolving by day 8 (p<0.001).Daytime cough dropped from 3.00 to 2.00 on day 4 and 1.00 on day 8 (p<0.001).By day 15, all symptoms (runny nose, throat phlegm, sore throat, and fever) resolved in both groups (p >0.05).In a subgroup analysis, no significant differences were observed in improvement rates between Azka without antibiotics and Prospan with antibiotics (p>0.05).Cough discomfort, daytime cough frequency, and throat pain improved similarly in both groups. Conclusion:Azka demonstrated comparable efficacy and safety to Prospan in treating pediatric ANP suggesting that it could be an effective herbal alternative.However, more large-scale studies are necessary to assess its long-term safety and efficacy, particularly in severe or chronic cases.