Efficacy of Natural Seawater Based Throat Spray in Acute Sore Throat Relief
FLASH
1 other identifier
interventional
360
1 country
16
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2017
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 6, 2017
CompletedFirst Submitted
Initial submission to the registry
November 16, 2017
CompletedFirst Posted
Study publicly available on registry
December 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2018
CompletedDecember 22, 2017
December 1, 2017
7 months
November 16, 2017
December 21, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Sore Throat Relief
Evaluation of sore throat relief using the 7-point sore throat relief scale (STRS)
Over the first three days
Secondary Outcomes (8)
Sore Throat Individual Symptoms Relief
Day 1, 2, 3, 4, 5, 5, 7 to 8.
Sore Throat Pain Intensity
Day 1, 2, 3, 4, 5, 5, 7 to 8.
Difficulty Swallowing
Day 1, 2, 3, 4, 5, 5, 7 to 8.
Swollen Throat
Day 1, 2, 3, 4, 5, 5, 7 to 8.
Overall efficacy assessed by the physician
Day 8
- +3 more secondary outcomes
Study Arms (2)
Angiflash
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- \. Adults (male or female) aged ≥ 18 years old.
- \. Patients with complaint of sore throat ≤ 72h.
- \. Sore throat exclusively due to upper respiratory tract infection (tonsillitis, pharyngitis, rhinopharyngitis).
- \. Clinical confirmation by the physician for the presence of typical signs (spontaneous pain, local inflammation) of acute pharyngitis or tonsillitis.
- \. Pain intensity scored by patient on the 5-point descriptive pain intensity scale as slight, mild or moderate.
- \. Willingness to provide written informed consent prior to perform of any study related procedure.
- \. Subjects agreeing to follow the study requirements during the whole study period (including forbidden medication and food supplements).
- \. Subjects agreeing not to modify their lifestyle habits during the whole study period (diet, physical activity).
- \. Subject affiliated to social security.
- \. Subject able to understand verbal and written local language and in capacity to fill-in patient diary by himself/herself.
You may not qualify if:
- \. Previous history of allergy or known intolerance to one of the following formulation ingredients: seawater, vegetable glycerin, mint, lemon, acacia honey, propolis, essential oils.
- \. Active Smokers.
- \. Fever \> 38°C at randomization.
- \. Past or current throat phlegmon.
- \. Past or current seasonal allergy.
- \. Past or current asthma.
- \. Past or current chronic rhinosinusitis.
- \. Past or current chronic obstructive pulmonary disease (COPD).
- \. Past or current ENT (Ear, Nose and Throat) cancer.
- \. Acute rhinosinusitis.
- \. Controlled or uncontrolled diabetes.
- \. Gastroesophageal reflux disease (GERD).
- \. Known immunodeficiency.
- \. Any painful condition that may distract attention from sore throat pain (ex: mouth ulcers etc.) or that requires analgesic usage.
- \. Any disease that may interfere with the study aim from investigator's opinion.
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
MUDr. Lenka Dybova
Brno, 602 00, Czechia
MUDr. Libor Hemzsky
Choltice, 533 61, Czechia
NEFROMED s.r.o.
Dejvice, 160 00, Czechia
MEDIGATE care s.r.o
Hradec Králové, 500 09, Czechia
MUDr. Petra Hoskova
Hradec Králové, 500 09, Czechia
MUDr. Jana Dvorakova s.r.o.
Hradec Králové, 500 11, Czechia
MUDr. Danuse Mikeschova
Karlovy Vary, 360 17, Czechia
Azita s.r.o.
Malšice, 108 00, Czechia
Fortmedica s.r.o.
Prague, 143 00, Czechia
GM ordinace s.r.o
Prague, 148 00, Czechia
MUDr Sylva Kohoutova
Prague, 160 00, Czechia
Ordinace Optima s.r.o
Prague, 161 00, Czechia
MUDr. Lenka Fejfarova
Prague, 164 00, Czechia
Saniga s.r.o.
Sokolov, 356 01, Czechia
MUDr. Jan Bartusek
Teplice, 415 01, Czechia
A-MEDICOS s.r.o.
Zlín, 760 01, Czechia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ivana Skardova, M.D.
MEDIGATE care s.r.o
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2017
First Posted
December 11, 2017
Study Start
November 6, 2017
Primary Completion
May 31, 2018
Study Completion
September 30, 2018
Last Updated
December 22, 2017
Record last verified: 2017-12
Data Sharing
- IPD Sharing
- Will not share