Clinical trial NCT02894372: Faringomoss Effectiveness in Inhibiting Acute Throat Pain and Discomfort
Official title: Faringomoss Effectiveness in Inhibiting Acute Throat Pain and Discomfort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spraying Behavior
Mouth Diseases
Throat Diseases
Throat Pain
Keywords: Oral spray
Topical sprays
Faringomoss
Local phytotherapy
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
Collaborators: name: Klaipėda University
name: Vita Longa Clinic
First posted: 2016-09-09
Enrollment: 96
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Symptoms changes during treatment assessed using the 100 mm visual analog scale (VAS)
timeFrame: The first, third, fifth and seventh treatment days
Secondary outcomes:
measure: Pharyngoscopic examination of the oropharyngeal mucosa of throat using Likert scale
timeFrame: After 7 days of treatment
measure: Secondary bleeding after surgery
timeFrame: Up to 7 days
measure: Use of medicines
timeFrame: Up to 7 days
measure: Period of time to notice the effect
timeFrame: Up to 7 days
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Lithuanian University of Health Sciences
Study officials:
affiliation: Hospital of Lithuanian University of Health Sciences, Otorhinolaryngology department
name: Nora Siupsinskiene, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Klaipėda University
name: Nora Siupsinskiene, Professor
role: PRINCIPAL_INVESTIGATOR
References: