Faringomoss Effectiveness in Inhibiting Acute Throat Pain and Discomfort
Primary Purpose
Spraying Behavior, Mouth Diseases, Throat Diseases
Status
Completed
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
Oral spray 1
Oral spray 2
Sponsored by
About this trial
This is an interventional treatment trial for Spraying Behavior focused on measuring Oral spray, Topical sprays, Faringomoss, Local phytotherapy
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
Sites / Locations
- Lithuanian University of Health Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Subjects with oral spray 1
Subjects with oral spray 2
Arm 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).
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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Secondary bleeding after surgery
We note if there was a bleeding after throat surgery during investigation time.
Use of medicines
We evaluate the amount of used standardized analgesics/anti-inflammatory drugs.
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.
Full Information
NCT ID
NCT02894372
First Posted
June 19, 2016
Last Updated
March 8, 2017
Sponsor
Lithuanian University of Health Sciences
Collaborators
Klaipėda University, Vita Longa Clinic
1. Study Identification
Unique Protocol Identification Number
NCT02894372
Brief Title
Faringomoss Effectiveness in Inhibiting Acute Throat Pain and Discomfort
Official Title
Faringomoss Effectiveness in Inhibiting Acute Throat Pain and Discomfort
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
November 1, 2016 (Actual)
Study Completion Date
December 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lithuanian University of Health Sciences
Collaborators
Klaipėda University, Vita Longa Clinic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spraying Behavior, Mouth Diseases, Throat Diseases, Throat Pain
Keywords
Oral spray, Topical sprays, Faringomoss, Local phytotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subjects with oral spray 1
Arm Type
Experimental
Arm 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).
Arm Title
Subjects with oral spray 2
Arm Type
Experimental
Arm 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).
Intervention Type
Device
Intervention Name(s)
Oral spray 1
Intervention Description
Research participants got topical oral spray immediately after surgery (hospital patients) and from the first doctor visit with pharyngeal disease (clinic outpatients).
Intervention Type
Device
Intervention Name(s)
Oral spray 2
Intervention Description
Research participants got topical oral spray immediately after surgery (hospital patients) and from the first doctor visit with pharyngeal disease (clinic outpatients).
Primary Outcome Measure Information:
Title
Symptoms changes during treatment assessed using the 100 mm visual analog scale (VAS)
Description
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.
Time Frame
The first, third, fifth and seventh treatment days
Secondary Outcome Measure Information:
Title
Pharyngoscopic examination of the oropharyngeal mucosa of throat using Likert scale
Description
Mucosal erythema, swelling, erosion, fibrin plaque, fistulas are evaluated using three points (0-2) Likert scale.
Time Frame
After 7 days of treatment
Title
Secondary bleeding after surgery
Description
We note if there was a bleeding after throat surgery during investigation time.
Time Frame
Up to 7 days
Title
Use of medicines
Description
We evaluate the amount of used standardized analgesics/anti-inflammatory drugs.
Time Frame
Up to 7 days
Title
Period of time to notice the effect
Description
We measure how many days or hours it took for the patient to notice the effect of the medical device.
Time Frame
Up to 7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nora Siupsinskiene, Professor
Organizational Affiliation
Hospital of Lithuanian University of Health Sciences, Otorhinolaryngology department
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nora Siupsinskiene, Professor
Organizational Affiliation
Klaipėda University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lithuanian University of Health Sciences
City
Kaunas
Country
Lithuania
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Faringomoss Effectiveness in Inhibiting Acute Throat Pain and Discomfort
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