Mouth Diseases, Spraying Behavior, Throat Diseases, Throat Pain
Conditions
Keywords
Oral spray, Topical sprays, Faringomoss, Local phytotherapy
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.
Interventions
DEVICEOral spray 1
Research participants got topical oral spray immediately after surgery (hospital patients) and from the first doctor visit with pharyngeal disease (clinic outpatients).
DEVICEOral spray 2
Research participants got topical oral spray immediately after surgery (hospital patients) and from the first doctor visit with pharyngeal disease (clinic outpatients).
Sponsors
Klaipėda University
Vita Longa Clinic
Lithuanian University of Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms changes during treatment assessed using the 100 mm visual analog scale (VAS) | The first, third, fifth and seventh treatment days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharyngoscopic examination of the oropharyngeal mucosa of throat using Likert scale | After 7 days of treatment | Mucosal erythema, swelling, erosion, fibrin plaque, fistulas are evaluated using three points (0-2) Likert scale. |
| Secondary bleeding after surgery | Up to 7 days | We note if there was a bleeding after throat surgery during investigation time. |
| Use of medicines | Up to 7 days | We evaluate the amount of used standardized analgesics/anti-inflammatory drugs. |
| Period of time to notice the effect | Up to 7 days | We measure how many days or hours it took for the patient to notice the effect of the medical device. |
Countries
Lithuania
Outcome results
None listed