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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
MVZ im Altstadt-Carree Fulda GmbH Fulda Germany
HNO Praxis Dr. Sonja Runge Neuenhagen Germany
Berufsausübungsgemeinschaft Dr. Jörg Schulze Jerichow Germany
Praxis Reinfeld Mitte Reinfeld Germany
Gemeinschaftspraxis Drs. Josef und Wilma Großkopf Wallerfing Germany

Other Sites

Site Name City Country Status
Ambenet GmbH Das Ambulante Behandlungsnetz Leipzig Germany
Medizentrum Essen Borbeck Essen Germany
Medizinisches Versorgungszentrum Jung GbR Deggingen Germany
Studienpraxis Heimeranplatz Munich Germany
medicoKIT GmbH Goch Germany
Hausarztzentrum Butendorf Gladbeck Germany
Pzfvmo Dfm mdtv Mltbool Tgohxgcfmxwioqzyy Munich Germany
Pzuefl Dfb Mldsblc Neustadt an der Donau Germany
Hus phas Wuppertal Germany
Pjalxrh Pgbqnhco Dnx mzpz Cwiidzowr Kwaxy Landsberg Am Lech Germany
Skwxcgtyzegeqc Dxrihczw Pozfflyfxewm ar Aprgxtzqt Hzgsizikhd Dresden Germany
Hwm Pnlxky Dxv Tkegju Duisburg Germany
Pvxsbtd Pmrieaxo Deu myjv Azohkpl Budeuebobd Blankenhain Germany
Zwufrwd fjr kffwzazep Ffupojimu Cologne Germany
Pgzntxa Pbpbajkc Plvhg Dpu mfhx Fmxekpcf Me Majec Nittendorf Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not yet recruiting
01.09.2025

Trial locations

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.

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 ID:
2025-521764-35-00
Protocol code:
6630-9450-01
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Testing benzydamine hydrochloride and dichlorobenzyl alcohol lozenges for relief of sore throat symptoms in patients with acute pharyngitis

    Not yet recruiting

    3 1 1
    Germany