Faringomoss Effectiveness in Inhibiting Acute Throat Pain and Discomfort

NCT ID: NCT02894372

Last Updated: 2017-03-13

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-12-30

Brief Summary

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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

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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.

Conditions

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Spraying Behavior Mouth Diseases Throat Diseases Throat Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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).

Group Type EXPERIMENTAL

Oral spray 1

Intervention Type DEVICE

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).

Group Type EXPERIMENTAL

Oral spray 2

Intervention Type DEVICE

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).

Intervention Type 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).

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Klaipėda University

OTHER

Sponsor Role collaborator

Vita Longa Clinic

UNKNOWN

Sponsor Role collaborator

Lithuanian University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Nora Siupsinskiene

Professor, Doctor of Medicine and Doctor of Philosophy (PhD)

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Lithuania

Other Identifiers

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Far1

Identifier Type: -

Identifier Source: org_study_id

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