Faringomoss Effectiveness in Inhibiting Acute Throat Pain and Discomfort

Study Overview
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Brief Summary
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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
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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.

Official Title
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Faringomoss Effectiveness in Inhibiting Acute Throat Pain and Discomfort

Conditions
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Spraying Behavior, Mouth Diseases, Throat Diseases, Throat Pain

Intervention / Treatment
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* Device: Oral spray 1
* Device: Oral spray 2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects with oral spray 1<br>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<br>* Research participants got topical oral spray immediately after surgery (hospital patients) and from the first doctor visit with pharyngeal disease (clinic outpatients).<br>|
| Experimental: Subjects with oral spray 2<br>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<br>* Research participants got topical oral spray immediately after surgery (hospital patients) and from the first doctor visit with pharyngeal disease (clinic outpatients).<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral spray, Topical sprays, Faringomoss, Local phytotherapy