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Completed

NCT Number: NCT02894372

Faringomoss Effectiveness in Inhibiting Acute Throat Pain and Discomfort

The purpose of the study was to assess the effectiveness of Faringomoss in reducing the throat discomfort and pain in patients with acute throat diseases and postoperative patients after throat surgeries.

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Key information

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lithuanian University of Health Sciences

Kaunas, Lithuania

About this study

Study objectives were:

  • To asses the symptoms of throat pain and discomfort after pharyngeal surgery in early postoperative period.
  • To evaluate those symptoms also in outpatient subjects with acute throat pain and discomfort.
  • To compare the data of different groups of patients who had received the topical throat spray with the placebo group.
  • To estimate the gender, age and surgery impact on the results.
  • To record the side effects of the topical sprays.

Patients were selected from Lithuanian University of Health Sciences Ear-Nose-Throat department and Vita Longa Clinic outpatients.

In random order research participants got a topical spray to use for 7 days after the surgery or from the start of acute throat infection. Neither the patient nor the investigator did not know if it was the medical device (Faringomoss) or the placebo. All the participants got a standard care and treatment with non-steroidal anti-inflammatory drugs.

The intent was to investigate about 70 - 80 subjects.

All the research subjects were tested using objective methods.

The confidentiality of the participation was guaranteed. The names were anonymous. The results were summarized.

Faringomoss is a topical spray, approved as a medical device. It is not harmful because it is made of vegetable oils.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients after throat surgeries: tonsillectomy, adenotonsillectomy, uvulopalatoplasty, uvulopalatopharyngoplasty
  • Patients with acute throat diseases: pharyngitis, tonsillitis, pharyngotonsillitis

Exclusion criteria

  • Purulent infection
  • Refusal to participate
  • Allergy to tested material

Treatment and study plan

Oral spray 1

Device

Research participants got topical oral spray immediately after surgery (hospital patients) and from the first doctor visit with pharyngeal disease (clinic outpatients).

Oral spray 2

Device

Research participants got topical oral spray immediately after surgery (hospital patients) and from the first doctor visit with pharyngeal disease (clinic outpatients).

Primary outcomes

  1. Symptoms changes during treatment assessed using the 100 mm visual analog scale (VAS)

    Time frame: The first, third, fifth and seventh treatment days

    Scale assessment: 0 point - no symptom, 100 points - strong symptom manifestation. Evaluated symptoms are: throat pain, ear pain, swallowing pain, difficult mouth opening, difficult swallowing, impaired nutrition, general condition, how symptoms are effecting life. If additional symptoms occur during investigation period, they are assessed too.

Secondary outcomes

  1. Pharyngoscopic examination of the oropharyngeal mucosa of throat using Likert scale

    Time frame: After 7 days of treatment

    Mucosal erythema, swelling, erosion, fibrin plaque, fistulas are evaluated using three points (0-2) Likert scale.

  2. Secondary bleeding after surgery

    Time frame: Up to 7 days

    We note if there was a bleeding after throat surgery during investigation time.

  3. Use of medicines

    Time frame: Up to 7 days

    We evaluate the amount of used standardized analgesics/anti-inflammatory drugs.

  4. Period of time to notice the effect

    Time frame: Up to 7 days

    We measure how many days or hours it took for the patient to notice the effect of the medical device.

Sponsors and collaborators

Lead sponsor

Lithuanian University of Health Sciences

Other

Collaborators

  • Klaipėda University
  • Vita Longa Clinic

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 9, 2016
Registry last updated
Mar 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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