A Comparative, Randomized, Double Blind, Parallel Group, Observational Clinical Trial Study to Evaluate Efficacy and Safety of a Filmogen Glycerol Throat Spray Containing Cw-Cyanidin Plant Premix Versus Saline Spray as Placebo in the treatment of patients Suffering from Wet (Productive) Cough

A cough is the sudden expulsion of air from the passages of the respiratory tract. Coughing is one of the body’s protective mechanisms. It serves the purpose of keeping our respiratory system clear. Cough can be described as productive or wet cough (also known as a chesty or mucous cough because the throat is wet and the mucus try to expel contaminants from the upper airways) or dry cough  – also known as tickly cough because this cough does not produce mucus and is known as a non-productive cough and is usually associated with throat irritation.

Cough is often generated due to the infection and irritation of the upper respiratory tract leading to the damage of the throat mucosa cells. Cellular damage cause generation of dead cell debris and creates a favorable ground for bacterial growth triggering inflammatory cascade, irritation and throat pain. Consequently our body reacts to humidify the throat surface and to stop the pain & irritation.

Almost all the currently available treatments are either expectorants & mucolytics or antitussives (used for dry, tickly coughs and are directed to soothe the throat, suppressing the cough reflex), antihistaminic or anti-bacterial, usually chemical in nature and therefore they are not suitable to repair damaged throat surface (injury can’t heal in the presence of chemicals).  Plant drugs, and saline solutions are also poorly effective.

Vitrobio observed that that in spite of the high prevalence of wet cough, there is no bandage, dressing, drug or device able to neutralize or to minimize the concentration of these impurities on the throat surface so as to act on the cause of the origin of cough.

ChSp-W formulation is a natural, safe, non-irritant and easily applicable filmogen bandage which could be used as a bandage over the throat surface and is capable to clean the throat surface instantly due to its hypertonic osmotic properties

This will be a comparative, randomized, double blind, parallel group, observational clinical trial study compared to Placebo. The study will begin with screening evaluation.

After screening, Patients satisfying all the inclusion criteria will be enrolled and randomly allocated in 2:1 ratio as per randomization schedule to receive test product or Comparator product (Placebo-0.9% NaCl saline solution spray). Block Randomization methodology will be employed for generating the list. Within the block the treatment will be distributed in the ratio of 2:1.

This study is designed to get exploitable results in at least 42 patients in the test group and 21 patients in the Placebo group. The main endpoint being wet cough, the patients will be selected only if they are suffering from wet cough (less than 7 days prior to screening) of any origin with related symptoms as Throat Pain, throat redness, Throat irritation/itching, (Fever if present)