CompletedNot Applicable

Clinical Trial of a Mouth and Throat Rinse for the Treatment of Acute Sore Throat

Ukraine154 participantsStarted 2024-03-25

Plain-language summary

The aim of this study is to confirm the efficacy, safety and tolerability of the Mouth and Throat Rinse in adult participants with acute sore throat (upper respiratory tract infection e.g., pharyngitis/laryngitis) compared to placebo.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subjects having clinical signs and symptoms of recent (less than 48 h) acute sore throat (upper respiratory tract infection) without signs of lower respiratory tract infection (total severity score for throat irritation baseline value ≥ 4). * Centor Score of 0 to 3 points at screening. * Female and male subjects with 18-75 years of age. Exclusion Criteria: * Known allergy to any of the components in the investigational product (Placebo or Verum) (i.e. SLS). * Centor Score of 4 points at screening. * Presence of exanthema. * Presence of oral mucosal plaques e.g., soor. * Presence of bacterial infection of the upper respiratory tract (confirmed by rapid screening test).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in total severity score of throat irritation for subjective and objective symptoms during the clinical investigation (comparison between verum and placebo)

Timeframe: Day 1 vs Day 4

Trial details

NCT IDNCT06244615

SponsorDr. August Wolff GmbH & Co. KG Arzneimittel

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-02-17

View on ClinicalTrials.gov More Sore-throat trials

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.