## 4 Discussion  
The cough is a common and troublesome symptom both in adults and children, which often requires a medical consultation. From the survey by [PERSON] et al. [6], it appeared that a cough becomes a concern for patients when it lasts more than one week and mainly when children are affected; as a result, patients seek medical advice for an appropriate therapy. Cough management usually involves the use of medications and over-the-counter (OTC) drugs, which block the cough reflex or improve sputum removal. Nowadays, a wide array of products are available over the counter for cough and colds, primarily antitussive, expectorants, mucolytic products that provide temporary relief of symptoms such as coughing and chest congestion. Notably, the majority of products are in form of liquid syrup which despite containing a high amount of sugar are not very palatable because of the bitterness of pharmaceutically active compounds. Among the OTC medications, symptomatic drugs (antitussives and mucolytic) are very popular either used as self-medication or as a prescribed treatment after medical consultation. The current clinical study was performed to assess both the effectiveness and safety of a novel gummy formulation for relieving acute cough. The product object of the current double blind, randomized, placebo-controlled, pilot clinical investigation is registered in the EU as a medical device (class IIa according to MDD 93/42/CEE) acting through a mechanical mechanism of action by forming a protective layer on the oropharyngeal mucosa due to the mucoadhesive properties of its functional compounds including acacia honey, mallow polysaccharides and Arabic gum as a base. The protective layer limits the contact of tissue with exogenous irritant agents such as smoking and environmental exposure to dust, smog, etc., which are known for exacerbating the cough reflex and causing local irritation on the oropharyngeal mucosa [24]. The results of the current study showed that IP significantly reduced both nighttime and daytime cough after 5 days of administration. Such significant effect was maintained until the end of treatment (day 10). In particular, sleep disturbances were completely resolved following the treatment with IP, thus ameliorating sleep quality and duration as a direct consequence of decreased nocturnal cough in subjects who took the IP compared to those in the placebo arm. This finding was also confirmed by results from the SF-36 questionnaire assessing patients' quality of life, which was significantly improved at the end of the treatment with fewer cough-related discomorts. A fundamental clinical goal when treating a cough is to improve the patients' quality of life. In fact, a cough negatively affects the quality of life of both adults and children. Recently, HRQL has become a key focus in clinical practice as an effective tool for supporting physicians' decisions and therapeutic approaches [24]. In our study, the QoL of all subjects was severely impaired at the baseline due to the high cough frequency. The functional effect of the investigated active product was clearly recorded at the end of treatment as all the domains and items of SF-36 were significantly improved compared to the placebo treatment. Moreover, sleep quality and duration assessed by LCQ were also significantly improved in the active treatment group. Other authors showed that treating a cough (either acute or persisting) with OTC or herbal preparations significantly contributes to improving symptoms and restoring sleep disorders [25]. A mixture of plants, including _M. sylvestris_, has been found to ease cough in asthmatic subjects already after 3 days of administration [26]. Regarding the non-pharmacological approach for relieving cough, most published studies found that patients may benefit from _P. sidoides_ consumption. Several clinical studies have been carried out in order to assess the efficacy of _Pelargonium sidoides_ root extract in relieving respiratory symptoms, such as a cough, mainly associated with respiratory infections.