Acute sore throat is one of the most common complaints associated with upper respiratory tract infections (URTIs) and a frequent reason for seeking medical care in primary care [1][2]. On average, adults experience 13.5 - 14.4 episodes of sore throat per 100 patient-years, while rates in children can reach 82.2 - 82.5 episodes per 100 patient-years [3]. Although acute sore throat is generally a self-limiting condition, its associated physical symptoms can impose a substantial psychosocial burden and reduce the quality of life [4][5].

Sore throat often involves more than localized discomfort. Pharyngeal inflammation can lead to throat pain, hoarseness, and cough. [6] A study reported that sore throat is typically the most bothersome symptom at the initial start of a cold, followed by nasal congestion and later, cough. While cough is less prominent during the early stages, it is frequently present throughout the course of illness and becomes increasingly disruptive in the later stages. The impact of cough on sleep and daily functioning contributes significantly to overall symptom burden, patient discomfort and reduced quality of life [7][8]. Notably, 54% - 60% of patients who sought medical care report experiencing moderate-to-severe sore throat and other associated symptoms, frequently accompanied by sleep disturbances and impaired daily functioning [9].

Sore throat aetiology is predominantly infectious, with most cases being of viral origin and group A streptococci (GAS) accounting for most bacterial infections [10]. Antibiotic therapy is generally not recommended for uncomplicated sore throat and should be reserved for confirmed GAS pharyngitis [1][3]. Of note, no or delayed antibiotic prescription is recommended in patients with a low-to-moderate clinical probability of GAS pharyngitis [1]. Therefore, the availability of topical throat preparations (e.g., topical lozenges, gargles and sprays) containing analgesics and/or nonsteroidal anti-inflammatory drugs plays an increasingly important role in the self-management of sore throat, cough and other symptoms.

Topical therapies deliver the active ingredients directly to the oropharyngeal mucosa, offering rapid symptomatic relief from acute sore throat [11]. These formulations differ substantially in delivery efficiency and onset of action. Sprays rely on coarse droplets to target affected areas but lose potency through swallowing [11]. Gargles are limited by the gag reflex, depositing active ingredients only in the anterior oral cavity in the anterior oral cavity [11]. In contrast, lozenges dissolve slowly, ensuring sustained drug delivery to all affected areas of the throat [11].

Scintigraphy analyses revealed significantly greater initial drug deposition in oropharyngeal mucosa from solid dosage forms (i.e., lozenge and tablet) compared to liquid formulations (i.e., throat sprays or gargles) [12]. While both solid forms exhibited similar clearance rates, lozenges maintained significantly higher mucosal drug retention than tablets in the first 20 minutes [12]. These findings indicate that lozenge formulation provides fast, effective and sustained delivery of active ingredients, offering distinct therapeutic advantages to those who experience pharyngeal inflammation.

This study investigated the efficacy of a multi-herbal menthol lozenge containing menthol and herbal extracts with analgesic, antiviral, antioxidant, antitussive and immune-boosting properties that could potentially help provide effective relief from acute sore throat and cough due to various aetiologies. Menthol and ginger (Zingiberaceae) are used in traditional medicine for pain relief, while liquorice (Glycyrrhizaglabra) acts as an antitussive agent. In addition, amla (Emblicaofficinalis) is a rich source of vitamin C with antioxidant activities, helping to support the immune system. Two independent patient cohorts (N = 100 each) were prospectively enrolled under the same study protocol to enhance analytical robustness. Results from each study group were analysed separately to evaluate consistency in efficacy and safety trends, providing complementary verification of treatment effects while maintaining analytical independence.

This study assessed the efficacy of a multi-herbal menthol lozenge for treating acute sore throat, cough and associated symptoms due to various aetiologies. The lozenges (when administered every 2 hours) demonstrated significant clinical relevance as a local analgesic and antitussive agent, with rapid onset of action that provided effective symptomatic relief and minimal AEs. Patients treated with the lozenges reported significant improvement in throat pain as early as 15 minutes post-administration.

The lozenges also achieved clinical and statistically significant reductions from baseline in inflammation, cough, hoarseness of voice and presence of exudates from 5 to 15 minutes post-administration (Figure 4 & Figure 5). The high global impression scores associated with treatment efficacy and safety that were reported by patients or their parents/caregivers confirmed the overall beneficial effect of the lozenges. Our study also supported the therapeutic efficacy and safety of the lozenges for as-needed use (up to 8 - 10 lozenges per day) throughout the 3-day treatment period. Notably, mild AEs were reported in only two patients, which ultimately were deemed unrelated to the study medication.

Figure 4. Proportion of patients with normal disease course having exudates in Cohorts A (green bars) and B (blue bars).

Figure 5. Proportion of patients with severe disease having exudates in Cohort A.

Topical therapies serve as a key component in the self-management of acute sore throat and cough, offering localised symptomatic relief through direct mucosal application. This targeted approach facilitates rapid analgesic and antitussive effects while minimising systemic exposure and associated risks. The lozenges contain menthol and herbal extracts with various medicinal properties, including liquorice (Glycyrrhizaglabra), ginger (Zingiberaceae) and amla (Emblicaofficinalis).

As a topical agent, menthol activates the transient receptor potential melastatin-8 (TRPM8) receptor, which may inhibit respiratory reflexes to mediate pain, reduce irritation and alleviate coughing [13][14]. Activation of the TRPM8 channels produces a cooling sensation, which serves as a counter-irritant that reduces pain from inflammation and respiratory irritation response. [14] Menthol’s broad antitussive effects are mediated through a reflex mechanism involving TRPM8-dependent activation of the afferent neurons and modulation of sensory irritant receptors in the airway [13][15].

Meanwhile, liquorice-derived bioactive compounds exhibit anti-inflammatory, antioxidant, antiviral and analgesic properties [16]. Its primary role in cough relief is often as part of compound formulations, where it serves as a sweet, palatable demulcent [17]. Traditionally, liquorice has been used to ease sore throats, relieve persistent cough and as an expectorant [18][19]. Its demulcent properties help form a protective film over mucous membranes, thus providing symptomatic relief as an antitussive. A randomised controlled trial (RCT) demonstrated that administering liquorice gargles 5 minutes before induction of anaesthesia significantly reduced the incidence and severity of postoperative sore throat and cough after tracheal intubation [20].

Ginger is known as a natural remedy used for common ailments like sore throats, coughs, fevers and digestive issues owing to its rich composition of bioactive compounds [21]. These bioactives contribute to ginger’s potent antioxidant and anti-inflammatory properties. Its expectorant action also helps loosen and expel phlegm, making it an effective option for cough relief [22]. A systematic review has highlighted the antioxidant benefits of dried ginger, supporting its use as a home remedy for the prevention and treatment of colds, sore throats and coughs [22]. Beyond respiratory symptoms, several RCTs have investigated the therapeutic potential of ginger across a range of inflammatory and painful conditions, such as primary dysmenorrhea and muscle pain, knee osteoarthritis and rheumatoid arthritis [23].

Separately, amla has a long history of use in traditional medicine for several therapeutic actions, including the reduction of sore throat and dryness of the mouth [24]. Clinical studies have shown its effectiveness in reducing sore throat and hoarseness following general anaesthesia with endotracheal intubation, as well as in alleviating cough during endobronchial ultrasound bronchoscopy [24][25]. In addition to its antitussive effects, a separate preclinical study also showed that continuous treatment with amla extract significantly alleviated postoperative and neuropathic pain in murine models [26].

Taken together, there is enough evidence to support the role of a lozenge formulation containing these herbal ingredients in the management of inflammatory conditions, such as acute sore throat and its associated symptoms, as demonstrated through the findings from this study. While this study’s single-arm, open-label design presents inherent limitations in the interpretation of results where we acknowledge the potential for a significant placebo effect—common in trials for cough and sore throat remedies—it is important to note that patients reported significant relief from throat pain and cough within just 15 minutes of administration. This rapid onset of symptom relief suggests that the observed effects are most likely attributable to the effectiveness of the therapy itself, rather than solely to placebo responses. Nonetheless, future studies are warranted to further validate these findings.

This study shows that a multi-herbal menthol lozenge (administered every 2 hours for up to 8 - 10 lozenges per day over 3 days) is effective in managing acute sore throat, cough and associated symptoms, demonstrating rapid symptomatic relief and good safety profile. This effective symptomatic relief is especially important in the clinical context of managing upper respiratory tract infections, where viral etiologies are common. By alleviating symptoms, such a lozenge could play a crucial role in supporting rational antibiotic stewardship, potentially reducing inappropriate use of antibiotics for viral infections. This approach not only enhances patient comfort but also contributes to broader public health efforts aimed at combating antibiotic resistance.

Medical writing and editorial support were funded by Procter & Gamble Health and provided by the Healthcare Practice of Weber Shandwick HK.

This manuscript was supported by Procter & Gamble, which funded the writing and preparation services of the manuscript. The authors declare that the funding source had no influence on the study design, data collection, analysis, interpretation of data, or the decision to submit the manuscript for publication.

All authors are employees of J. B. CHEMICALS & PHARMACEUTICALS LIMITED, the manufacturer of the product discussed in this manuscript.

All authors contributed equally to the conceptualisation, investigation, analysis and review of this study.

All patients or their parents/caregivers provided written, informed consent prior to study enrolment.

The data that support the findings of this study are available from the corresponding author upon reasonable request.

This study was carried out in accordance with the Code of Ethics of the World Medical Association (Declaration of Helsinki). Approval was granted by an independent ethics committee (Protocol ID: IS/06/DML/07/10).

Additional supporting information may be found in the online version of this article at the publisher’s website (Figures S1-S3).

Figure S1. Changes in disease severity among patients with normal disease course over time in Cohort A.

Figure S2. Changes in disease severity among patients with severe disease course over time in Cohort A.

Figure S3. Changes in disease severity among patients with normal disease course over time in Cohort B.