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Faringomoss Effectiveness in Inhibiting Acute Throat Pain and Discomfort

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ClinicalTrials.gov Identifier: NCT02894372
Recruitment Status : Completed
First Posted : September 9, 2016
Last Update Posted : March 13, 2017
Sponsor:
Collaborators:
Klaipėda University
Vita Longa Clinic
Information provided by (Responsible Party):
Nora Siupsinskiene, Lithuanian University of Health Sciences

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.

Condition or disease Intervention/treatment Phase
Spraying Behavior Mouth Diseases Throat Diseases Throat Pain Device: Oral spray 1 Device: Oral spray 2 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Faringomoss Effectiveness in Inhibiting Acute Throat Pain and Discomfort
Study Start Date : January 2015
Actual Primary Completion Date : November 1, 2016
Actual Study Completion Date : December 30, 2016

Arm Intervention/treatment
Experimental: 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).
Device: 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).

Experimental: 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).
Device: 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).




Primary Outcome Measures :
  1. Symptoms changes during treatment assessed using the 100 mm visual analog scale (VAS) [ Time Frame: 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 Outcome Measures :
  1. Pharyngoscopic examination of the oropharyngeal mucosa of throat using Likert scale [ Time Frame: After 7 days of treatment ]
    Mucosal erythema, swelling, erosion, fibrin plaque, fistulas are evaluated using three points (0-2) Likert scale.

  2. Secondary bleeding after surgery [ Time Frame: Up to 7 days ]
    We note if there was a bleeding after throat surgery during investigation time.

  3. Use of medicines [ Time Frame: Up to 7 days ]
    We evaluate the amount of used standardized analgesics/anti-inflammatory drugs.

  4. Period of time to notice the effect [ Time Frame: Up to 7 days ]
    We measure how many days or hours it took for the patient to notice the effect of the medical device.



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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02894372


Locations
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Lithuania
Lithuanian University of Health Sciences
Kaunas, Lithuania
Sponsors and Collaborators
Lithuanian University of Health Sciences
Klaipėda University
Vita Longa Clinic
Investigators
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Principal Investigator: Nora Siupsinskiene, Professor Hospital of Lithuanian University of Health Sciences, Otorhinolaryngology department
Principal Investigator: Nora Siupsinskiene, Professor Klaipėda University

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Responsible Party: Nora Siupsinskiene, Professor, Doctor of Medicine and Doctor of Philosophy (PhD), Lithuanian University of Health Sciences
ClinicalTrials.gov Identifier: NCT02894372     History of Changes
Other Study ID Numbers: Far1
First Posted: September 9, 2016    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Nora Siupsinskiene, Lithuanian University of Health Sciences:
Oral spray
Topical sprays
Faringomoss
Local phytotherapy

Additional relevant MeSH terms:
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Mouth Diseases
Stomatognathic Diseases