Status:
UNKNOWN
Efficacy of Natural Seawater Based Throat Spray in Acute Sore Throat Relief
Lead Sponsor:
Laboratoire de la Mer
Conditions:
Sore Throat
Eligibility:
All Genders
18+ years
Phase:
NA
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 sor...
Eligibility Criteria
Inclusion
- 1\. Adults (male or female) aged ≥ 18 years old.
- 2\. Patients with complaint of sore throat ≤ 72h.
- 3\. Sore throat exclusively due to upper respiratory tract infection (tonsillitis, pharyngitis, rhinopharyngitis).
- 4\. Clinical confirmation by the physician for the presence of typical signs (spontaneous pain, local inflammation) of acute pharyngitis or tonsillitis.
- 5\. Pain intensity scored by patient on the 5-point descriptive pain intensity scale as slight, mild or moderate.
- 6\. Willingness to provide written informed consent prior to perform of any study related procedure.
- 7\. Subjects agreeing to follow the study requirements during the whole study period (including forbidden medication and food supplements).
- 8\. Subjects agreeing not to modify their lifestyle habits during the whole study period (diet, physical activity).
- 9\. Subject affiliated to social security.
- 10\. Subject able to understand verbal and written local language and in capacity to fill-in patient diary by himself/herself.
Exclusion
- 1\. Previous history of allergy or known intolerance to one of the following formulation ingredients: seawater, vegetable glycerin, mint, lemon, acacia honey, propolis, essential oils.
- 2\. Active Smokers.
- 3\. Fever \> 38°C at randomization.
- 4\. Past or current throat phlegmon.
- 5\. Past or current seasonal allergy.
- 6\. Past or current asthma.
- 7\. Past or current chronic rhinosinusitis.
- 8\. Past or current chronic obstructive pulmonary disease (COPD).
- 9\. Past or current ENT (Ear, Nose and Throat) cancer.
- 10\. Acute rhinosinusitis.
- 11\. Controlled or uncontrolled diabetes.
- 12\. Gastroesophageal reflux disease (GERD).
- 13\. Known immunodeficiency.
- 14\. Any painful condition that may distract attention from sore throat pain (ex: mouth ulcers etc.) or that requires analgesic usage.
- 15\. Any disease that may interfere with the study aim from investigator's opinion.
- 16\. Evidence of mouth breathing or severe coughing.
- 17\. Patient with severe pain intensity on 5-point descriptive pain intensity scale.
- 18\. Subjects taking:
- chronic treatment for throat or other ENT pathology,
- current antibiotherapy or stopped less than 2 weeks before inclusion,
- chronic treatment (\>3 months) with local or systemic corticotherapy, or immunotherapy,
- local or systemic antihistaminic.
- 19\. Subjects refusing to stop at entry into the study:
- throat spray, lozenge, pastille,
- local throat or systemic analgesic,
- medicated confectionary,
- nasal wash and spray,
- nasal corticosteroid or antihistaminic nasal spray,
- medication to gargle,
- honey, propolis, or any sore throat home remedies.
- 20\. Known liver disease or hypersensitivity to paracetamol.
- 21\. Pregnant, breastfeeding or seeking pregnancy women.
- 22\. Positive result from rapid strep throat test.
- 23\. Subjects already included once in this study.
- 24\. Subjects participating in another clinical trial or in the exclusion period to another study.
- 25\. Subjects having a member of his/her home who is currently participating to this study.
Key Trial Info
Start Date :
November 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2018
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT03369132
Start Date
November 6 2017
End Date
September 30 2018
Last Update
December 22 2017
Active Locations (16)
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1
MUDr. Lenka Dybova
Brno, Czechia, 602 00
2
MUDr. Libor Hemzsky
Choltice, Czechia, 533 61
3
NEFROMED s.r.o.
Dejvice, Czechia, 160 00
4
MEDIGATE care s.r.o
Hradec Králové, Czechia, 500 09