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Study of benzydamine hydrochloride and dichlorobenzyl alcohol lozenges for treating acute pharyngitis symptoms

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on testing lozenges containing benzydamine hydrochloride and 2,4-dichlorobenzyl alcohol for treating acute pharyngitis, which is a condition causing throat inflammation and soreness. The study aims to determine if these lozenges are effective in providing symptom relief for people with acute throat inflammation.

The study will compare three different treatments: DoriDuo lozenges (containing both active ingredients), Mebocaína Anti-Inflam lozenges (containing the same active ingredients), and a placebo. The medications will be given as throat lozenges that dissolve in the mouth. The maximum daily dose will be 25.2 mg, and the treatment will last up to 4 weeks.

During the study, participants will take the assigned lozenges and have their throat soreness levels monitored, particularly in the first two hours after taking the medication. The study is designed to show whether the new medication works better than the placebo and is at least as effective as the existing treatment. All medications will be given in a way that neither the patients nor the doctors know which treatment is being used.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    Your throat condition will be evaluated using the Throat Pain Assessment (TPA) scale to confirm acute pharyngitis

    Your throat soreness will be measured using the Throat Soreness Scale (TSS)

    The evaluation will verify that your symptoms started within the last 30 hours

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive one of three treatments:

    - DoriDuo lozenges (containing benzydamine hydrochloride and dichlorobenzyl alcohol)

    - Mebocaína Anti-Inflam lozenges (containing benzydamine hydrochloride and dichlorobenzyl alcohol)

    - Placebo lozenges (containing no active ingredients)

  3. Step 3

    First dose administration

    You will receive your first lozenge for oral use

    The lozenge should be allowed to dissolve slowly in your mouth

    Your throat soreness will be monitored for 2 hours after taking the first dose

  4. Step 4

    Monitoring period

    Your throat soreness levels will be recorded at specific intervals during the first 2 hours

    You will need to use your personal electronic device (phone, tablet, or computer) to record your symptoms

  5. Step 5

    Study duration

    The study will continue from September 2025 to April 2026

    Your individual participation duration will be determined by your assigned treatment protocol

Who can join the trial?

7 criteria

  • Must be at least 18 years old
  • Must provide signed informed consent (written agreement to participate in the study after being informed about its details)
  • Must have acute pharyngitis diagnosed by a doctor with a TPA score of 5 points or higher (TPA is a scoring system doctors use to assess throat infection symptoms)
  • Symptoms must have started within the last 30 hours before joining the study
  • Must have a throat soreness score of 7 or higher on the TSS scale (TSS measures how severe your throat pain is)
  • Must have access to a personal electronic device with internet connection (such as a mobile phone, smartphone, tablet, or computer) that can be used throughout the entire study period
  • Can be either male or female

Who cannot join the trial?

13 criteria

  • Age below 18 years or above 65 years
  • Pregnancy or breastfeeding
  • Known allergies to benzydamine hydrochloride or dichlorobenzyl alcohol (active ingredients in the medication)
  • Current use of other medications for throat pain or inflammation
  • Severe throat infection requiring antibiotics
  • History of chronic throat conditions
  • Recent surgery in mouth or throat area (within last 3 months)
  • Active mouth or throat wounds
  • Participation in other clinical trials within the last 30 days
  • Inability to follow study procedures or provide informed consent
  • Serious medical conditions that could interfere with the study
  • History of substance abuse or alcohol dependency
  • Mental conditions that could affect study participation
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Investigated drugs

  • Benzydamine hydrochloride

    is a medication that helps reduce pain and inflammation in the throat. It works as a local anti-inflammatory and pain-relieving agent. When used in throat lozenges, it helps provide relief from sore throat symptoms and discomfort associated with pharyngitis.

  • Dichlorobenzyl alcohol

    is an antiseptic medication that helps fight bacteria in the throat. When combined in lozenges with benzydamine hydrochloride, it helps provide both antimicrobial action and pain relief for people suffering from throat infections and inflammation.

What is already known about the treatment

  • Benzydamine hydrochloride

    An anti-inflammatory and local analgesic medication administered in lozenge form that dissolves slowly in the mouth to treat acute throat pain and inflammation. This medication works by blocking prostaglandin production and stabilizing cell membranes, providing both pain relief and reduction of inflammation in the throat tissues. It belongs to the class of non-steroidal anti-inflammatory drugs (NSAIDs) and is commonly used in the treatment of acute pharyngitis and other inflammatory conditions of the mouth and throat.

  • Dichlorobenzyl alcohol

    A locally-acting antiseptic and mild anesthetic medication delivered in lozenge form for treating throat infections and inflammation. It works by disrupting bacterial cell membranes and providing a mild numbing effect to reduce throat pain and discomfort. This compound belongs to the antiseptic class of medications and is frequently combined with other active ingredients in throat lozenges to provide both antimicrobial activity and pain relief in acute pharyngitis.

Investigated diseases

Acute pharyngitis – An inflammatory condition affecting the throat and pharynx (the area behind the mouth and soft palate). The condition typically develops suddenly and causes soreness, scratchiness, and pain in the throat area. The pharynx often becomes red and swollen, making it uncomfortable to swallow. Symptoms usually include throat discomfort, which may be accompanied by a scratchy sensation. The condition can make speaking and eating difficult due to throat pain and irritation.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521764-35-00Protocol code6630-9450-01Estimated enrolment810 patientsSponsorMEDICE Arzneimittel Puetter GmbH & Co. KG

sourced from the EU Clinical Trials Register and site verification

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