Prospective, randomized, double-blind, placebo-controlled, multicentre clinical trial to assess the efficacy and tolerability of natural seawater based throat spray among adult patients with acute sore throat.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
360
throat spray (20 ml) containing hypertonic seawater, vegetable glycerin, natural mint, acacia honey, propolis extract, essential oils of thyme linalool, ravintsara and wintergreen, natural lemon flavor.
water based throat spray matching Angiflash for posology, dispensed volume, shape and size.
MUDr. Lenka Dybova
Brno, Czechia
RECRUITINGMUDr. Libor Hemzsky
Choltice, Czechia
Sore Throat Relief
Evaluation of sore throat relief using the 7-point sore throat relief scale (STRS)
Time frame: Over the first three days
Sore Throat Individual Symptoms Relief
Evaluation of relief of sore throat individual symptoms (dry throat, burning/painful sensation, hoarseness/husky voice, painful talk, painful swallowing, irritation, prickly sensation/tingle, scratchy/itchy throat) using a 10-point rating scale
Time frame: Day 1, 2, 3, 4, 5, 5, 7 to 8.
Sore Throat Pain Intensity
Change from baseline of the Sore Throat Pain Intensity using a Visual Analog Scale (VAS) (STPIS)
Time frame: Day 1, 2, 3, 4, 5, 5, 7 to 8.
Difficulty Swallowing
Change from baseline of the difficulty of swallowing using a VAS (DSS)
Time frame: Day 1, 2, 3, 4, 5, 5, 7 to 8.
Swollen Throat
Change from baseline of the swollen throat using a VAS (SwoTS)
Time frame: Day 1, 2, 3, 4, 5, 5, 7 to 8.
Overall efficacy assessed by the physician
Overall efficacy assessed by the physician using a 5-point descriptive scale
Time frame: Day 8
Compliance: assessment of the number of use per day and the number of spray per use
Assessment of the patient usage: frequency per day and number of spray per use
Time frame: Day 1, 2, 3, 4, 5, 5, 7 to 8.
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NEFROMED s.r.o.
Dejvice, Czechia
RECRUITINGMEDIGATE care s.r.o
Hradec Králové, Czechia
RECRUITINGMUDr. Petra Hoskova
Hradec Králové, Czechia
RECRUITINGMUDr. Jana Dvorakova s.r.o.
Hradec Králové, Czechia
RECRUITINGMUDr. Danuse Mikeschova
Karlovy Vary, Czechia
RECRUITINGAzita s.r.o.
Malšice, Czechia
RECRUITINGFortmedica s.r.o.
Prague, Czechia
RECRUITINGGM ordinace s.r.o
Prague, Czechia
RECRUITING...and 6 more locations
Product Satisfaction
Assessment of the overall satisfaction using a 5-point descriptive scale
Time frame: Day 8
Incidence of adverse events occuring during the study
Number of adverse events and serious events occuring during the study and evaluation of the severity and causality.
Time frame: Day 1, 2, 3, 4, 5, 5, 7 to 8.