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.

Study Overview

• Status: Completed
• Conditions: Mouth Diseases; Throat Pain; Spraying Behavior; Throat Diseases
• Intervention / Treatment: Device: Oral spray 1; Device: Oral spray 2

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lithuania
  • Kaunas, Lithuania
    • Lithuanian University of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subjects with oral spray 1; Research subjects, who got oral spray 1. Spray was used 3 times a day 3 sprays a time for seven days. Spray 1 was Faringomoss or simple oily oral spray (unknown because of double blind method).	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).
Experimental: Subjects with oral spray 2; Research subjects, who got oral spray 2. Spray was used 3 times a day 3 sprays a time for seven days. Spray 2 was Faringomoss or simple oily oral spray (unknown because of double blind method).	Device: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 bleeding after surgery	We note if there was a bleeding after throat surgery during investigation time.	Up to 7 days
Use of medicines	We evaluate the amount of used standardized analgesics/anti-inflammatory drugs.	Up to 7 days
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

Collaborators and Investigators

• Sponsor: Lithuanian University of Health Sciences
• Collaborators: Klaipėda University; Vita Longa Clinic
• Investigators: Principal Investigator: Nora Siupsinskiene, Professor, Klaipėda university; Principal Investigator: Nora Siupsinskiene, Professor, Hospital of Lithuanian University of Health Sciences, Otorhinolaryngology department

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): December 30, 2016

Study Registration Dates

• First Submitted: June 19, 2016
• First Submitted That Met QC Criteria: September 4, 2016
• First Posted (Estimate): September 9, 2016

Study Record Updates

• Last Update Posted (Actual): March 13, 2017
• Last Update Submitted That Met QC Criteria: March 8, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Oral spray; Topical sprays; Faringomoss; Local phytotherapy
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases
• Other Study ID Numbers: Far1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED