Faringomoss Effectiveness in Inhibiting Acute Throat Pain and Discomfort
NCT ID: NCT02894372
Last Updated: 2017-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
96 participants
INTERVENTIONAL
2015-01-31
2016-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Subjects with oral spray 1
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).
Oral spray 1
Research participants got topical oral spray immediately after surgery (hospital patients) and from the first doctor visit with pharyngeal disease (clinic outpatients).
Subjects with oral spray 2
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).
Oral spray 2
Research participants got topical oral spray immediately after surgery (hospital patients) and from the first doctor visit with pharyngeal disease (clinic outpatients).
Interventions
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Oral spray 1
Research participants got topical oral spray immediately after surgery (hospital patients) and from the first doctor visit with pharyngeal disease (clinic outpatients).
Oral spray 2
Research participants got topical oral spray immediately after surgery (hospital patients) and from the first doctor visit with pharyngeal disease (clinic outpatients).
Eligibility Criteria
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Inclusion Criteria
* Patients with acute throat diseases: pharyngitis, tonsillitis, pharyngotonsillitis
Exclusion Criteria
* Refusal to participate
* Allergy to tested material
6 Years
ALL
No
Sponsors
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Klaipėda University
OTHER
Vita Longa Clinic
UNKNOWN
Lithuanian University of Health Sciences
OTHER
Responsible Party
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Nora Siupsinskiene
Professor, Doctor of Medicine and Doctor of Philosophy (PhD)
Principal Investigators
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Nora Siupsinskiene, Professor
Role: PRINCIPAL_INVESTIGATOR
Hospital of Lithuanian University of Health Sciences, Otorhinolaryngology department
Nora Siupsinskiene, Professor
Role: PRINCIPAL_INVESTIGATOR
Klaipėda University
Locations
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Lithuanian University of Health Sciences
Kaunas, , Lithuania
Countries
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Other Identifiers
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Far1
Identifier Type: -
Identifier Source: org_study_id
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