Faringomoss Effectiveness in Inhibiting Acute Throat Pain and Discomfort

Lithuanian University of Health Sciences

Status: Completed

Conditions: Throat Pain; Spraying Behavior; Mouth Diseases; Throat Diseases

Treatments: Device: Oral spray 2; Device: Oral spray 1

Study type: Interventional

Funder types: Other

Identifiers

NCT02894372

Far1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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96 participants in 2 patient groups

Subjects with oral spray 1

Experimental group

Description:

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).

Treatment:

Device: Oral spray 1

Subjects with oral spray 2

Experimental group

Description:

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).

Treatment:

Device: Oral spray 2