Faringomoss Effectiveness in Inhibiting Acute Throat Pain and Discomfort

Mouth Diseases Clinical Trial

Official title:

Faringomoss Effectiveness in Inhibiting Acute Throat Pain and Discomfort

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02894372
• Other study ID #: Far1
• Status: Completed
• Phase: N/A
• First received: June 19, 2016
• Last updated: March 8, 2017
• Start date: January 2015
• Est. completion date: December 30, 2016

Study information

• Verified date: March 2017
• Source: Lithuanian University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Study objectives were:

1. To asses the symptoms of throat pain and discomfort after pharyngeal surgery in early postoperative period.

2. To evaluate those symptoms also in outpatient subjects with acute throat pain and discomfort.

3. To compare the data of different groups of patients who had received the topical throat spray with the placebo group.

4. To estimate the gender, age and surgery impact on the results.

5. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: December 30, 2016
• Est. primary completion date: November 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mouth Diseases
• Spraying Behavior
• Throat Diseases
• Throat Pain

Intervention

Device:
• Oral spray 1
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
Research participants got topical oral spray immediately after surgery (hospital patients) and from the first doctor visit with pharyngeal disease (clinic outpatients).

Locations

Country	Name	City	State
Lithuania	Lithuanian University of Health Sciences	Kaunas

Sponsors (3)

Lead Sponsor	Collaborator
Lithuanian University of Health Sciences	Klaipeda University, Vita Longa Clinic

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms changes during treatment assessed using the 100 mm visual analog scale (VAS)	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.	The first, third, fifth and seventh treatment days
Secondary	Pharyngoscopic examination of the oropharyngeal mucosa of throat using Likert scale	Mucosal erythema, swelling, erosion, fibrin plaque, fistulas are evaluated using three points (0-2) Likert scale.	After 7 days of treatment
Secondary	Secondary bleeding after surgery	We note if there was a bleeding after throat surgery during investigation time.	Up to 7 days
Secondary	Use of medicines	We evaluate the amount of used standardized analgesics/anti-inflammatory drugs.	Up to 7 days
Secondary	Period of time to notice the effect	We measure how many days or hours it took for the patient to notice the effect of the medical device.	Up to 7 days