NCT02894372

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 9, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2016

Completed
Last Updated

March 13, 2017

Status Verified

March 1, 2017

Enrollment Period

1.8 years

First QC Date

June 19, 2016

Last Update Submit

March 8, 2017

Conditions

Spraying BehaviorMouth DiseasesThroat DiseasesThroat Pain

Keywords

Oral sprayTopical spraysFaringomossLocal phytotherapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Pharyngoscopic examination of the oropharyngeal mucosa of throat using Likert scale

    After 7 days of treatment

  • Secondary bleeding after surgery

    Up to 7 days

  • Use of medicines

    Up to 7 days

  • Period of time to notice the effect

    Up to 7 days

Study Arms (2)

Subjects with oral spray 1

EXPERIMENTAL

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

Subjects with oral spray 2

EXPERIMENTAL

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

Interventions

Oral spray 1DEVICE

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 1
Oral spray 2DEVICE

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

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients after throat surgeries: tonsillectomy, adenotonsillectomy, uvulopalatoplasty, uvulopalatopharyngoplasty
  • Patients with acute throat diseases: pharyngitis, tonsillitis, pharyngotonsillitis

You may not qualify if:

  • Purulent infection
  • Refusal to participate
  • Allergy to tested material

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lithuanian University of Health Sciences

Kaunas, Lithuania

Location

MeSH Terms

Conditions

Mouth DiseasesPharyngitis

Condition Hierarchy (Ancestors)

Stomatognathic DiseasesRespiratory Tract InfectionsInfectionsPharyngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Nora Siupsinskiene, Professor

    Hospital of Lithuanian University of Health Sciences, Otorhinolaryngology department

    PRINCIPAL INVESTIGATOR

  • Nora Siupsinskiene, Professor

    Klaipėda University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Doctor of Medicine and Doctor of Philosophy (PhD)

Study Record Dates

First Submitted

June 19, 2016

First Posted

September 9, 2016

Study Start

January 1, 2015

Primary Completion

November 1, 2016

Study Completion

December 30, 2016

Last Updated

March 13, 2017

Record last verified: 2017-03

Locations

LI(1)