Introduction 

Pediatric upper respiratory tract infections (URTIs) are one of the leading causes of hospital visits. Antibiotic overuse in children has lowered immunity, extensive resistance among microorganisms and increased susceptibility to secondary bacterial infection. Nonsynthetic antibiotic alternatives like curcumin, are used in traditional Asian medicine to treat infectious ailments independently for viral URTIs or in combination with antibiotics for bacterial URTIs. A child-friendly formulation of curcumin with quick and targeted symptomatic relief and minimum side effects would be preferred. This study evaluated a novel curcumin preparation with improved bioavailability from a unique pastille formulation comprising of a curcumin-protein conjugate, which dissolves or disintegrates slowly in the mouth. A study reported nine times higher bioavailability of curcumin in pastille form in the buccal mucosa than curcumin in hard gelatin capsules ingested orally.

Aim

To evaluate the comparative safety and efficacy of curcumin 100 mg pastille when used as monotherapy for acute, viral, uncomplicated URTI and as an adjuvant with standard antibiotics in acute uncomplicated bacterial URTIs in comparison with standard antibiotic treatment alone in children.

Patient Profile 

Method

Study Design

• Open-label, multi-center, comparative, randomized study
• Group A with viral infection received only curcumin 100 mg pastille thrice daily for the first 2 days followed by curcumin 100 mg pastille twice daily for the next 2 days
• Group B1 with bacterial infection received only antibiotics (amoxicillin 20 mg/kg twice daily) for 5 days
• Group B2 with bacterial infection received curcumin 100 mg pastille thrice daily for the first 2 days followed by curcumin 100 mg pastille twice daily for the next 2 days with antibiotics (amoxicillin 20 mg/kg twice daily) for 5 days

Endpoints

• Tonsillopharyngitis Severity Score (TSS): sore throat, difficulty in swallowing, increased salivation, and redness of the throat
• Tonsillopharyngitis Assessment (TPA): oral temperature, oropharyngeal color, tonsil size, number of oropharyngeal exanthems, number of anterior cervical lymph nodes, maximum tenderness of a few anterior cervical lymph nodes, size of the largest anterior cervical lymph nodes, and size of the anterior cervical lymph nodes
• Global Assessment of Efficacy (used a 5-point improvement scale: 1- very good; 2- good; 3- moderate, 4- negligible; 5- worse) and Visual Analogue Scale (VAS, throat infection)
• URTI questionnaire: nasal congestion, sneezing, runny nose, fever, cough and sore throat
• Sore Throat Pain Intensity Scale (STPIS), Difficulty Swallowing Scale (DSS), and Swollen Throat Scale (SwoTS, assessed sore throat discomfort)
• Global Tolerability assessment: 4 point scale with 1 as excellent tolerability (no adverse event reported), rating of 2 as good tolerability (mild adverse event), 3 rating as satisfactory or fair tolerability (moderate to severe adverse event) and 4 as poor tolerability (severe or serious adverse events)

Results 

Efficacy 

• Curcumin pastille monotherapy significantly reduced URTI symptoms such as sore throat, dysphagia, erythema, common cold, sinusitis, and laryngitis at visit 3 and after 5 days of treatment in the viral sub-group 
• It also significantly reduced total TSS by 96.3% on visit 3 from baseline in the viral sub-group
• In the bacterial infection subgroup, curcumin pastille in combination with antibiotics significantly and rapidly improved symptoms like sore throat, dysphagia, erythema, common cold, sinusitis, and laryngitis as compared to those receiving antibiotics alone
• Curcumin and antibiotic combination showed a significant reduction in TSS by 99.49% on visit 3 in group B2, whereas group B1 (treated only with antibiotics) showed a reduction in TSS by 97.26% from the baseline (p=0.806)
• Curcumin pastille significantly reduced STPIS, DSS and SwoTS from the baseline scores in group A (by 95.20%, 96.40% & 95.45%, resp.) and group B2 (100% reduction at visit 3); STPIS, DSS and SwoTS values in group B1 were reduced by 97.92%, 99.40%, & 97.50%, resp. from baseline
• Curcumin treatment lowered the TPA scores in group A; it showed a 100% reduction in TPA score at visit 3 for Group B2 (Figure 1)
• The Global Assessment of the Efficacy of treatment for group A was rated 1 and 1.09, for group B2 as 1.12 and 1.15 and for group B1 as 1.11 and 1.11 by the investigator and patient, respectively

Figure 1: Effect of treatment on Tonsillo-Pharyngitis Assessment score in URTI patients

Safety   

• Curcumin pastille treatment was well tolerated by the patients of all groups, without side effects or complications 
• The Global Assessment of Tolerability of treatment for group A was 1.82 and 1.64, 1.14 and 1.18 for group B1 and 1.12 and 1.15 for group B2 by investigator and patient, respectively

Conclusion 

• Curcumin pastille effectively alleviated symptoms of both, viral URTIs independently, and bacterial URTIs in combination with antibiotics, via buccal mucosal absorption with no adverse reactions
• This study provided clinical evidence of reducing viral URTI symptoms within five days of curcumin pastille monotherapy that could reduce the irrational usage of antibiotics
• Curcumin pastille in combination with antibiotics exhibited comparatively quicker improvement of all symptoms of URTI than antibiotics alone, making it an effective adjuvant with antibiotics for managing bacterial URTI
• Enhanced bioavailability and consumer-friendly formulation made curcumin pastille an excellent choice for quicker symptomatic relief in URTI

J Indian Med Assoc 2025; 123(10): 53-8