Spraying BehaviorNCT02894372
Faringomoss Effectiveness in Inhibiting Acute Throat Pain and Discomfort
A study testing Oral spray 1 and Oral spray 2 in people with Spraying Behavior and Mouth Diseases, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Spraying Behavior, Mouth Diseases, Throat Diseases
- What is being tested?
- Oral spray 1 and Oral spray 2
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteLithuania
- Study dates
- Jan 2015to 30 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients after throat surgeries: tonsillectomy, adenotonsillectomy, uvulopalatoplasty, uvulopalatopharyngoplasty
- Patients with acute throat diseases: pharyngitis, tonsillitis, pharyngotonsillitis
Who cannot join
- Purulent infection
- Refusal to participate
- Allergy to tested material
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Spraying Behavior, Mouth Diseases, Throat Diseases, Throat Pain
- Being tested
- Oral spray 1, Oral spray 2
- Keywords
- Oral spray, Topical sprays, Faringomoss, Local phytotherapy
- Medical subject headings
- Mouth Diseases, Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Device: Oral spray 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The first, third, fifth and seventh treatment days
Secondary outcomes (4)
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.
Measured: After 7 days of treatment
Secondary bleeding after surgery
We note if there was a bleeding after throat surgery during investigation time.
Measured: Up to 7 days
Use of medicines
We evaluate the amount of used standardized analgesics/anti-inflammatory drugs.
Measured: Up to 7 days
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.
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startJan 2015
- Primary completion1 Nov 2016
- Study completion30 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spraying BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Klaipėda University, Vita Longa Clinic
- Responsible party
- Principal investigator, Nora Siupsinskiene, Lithuanian University of Health Sciences
- Investigators
- Nora Siupsinskiene, Professor, Principal investigator, Hospital of Lithuanian University of Health Sciences, Otorhinolaryngology departmentNora Siupsinskiene, Professor, Principal investigator, Klaipėda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02894372
- Sponsor's protocol ID
- Far1
- Status last verified
- Mar 2017
- First submitted
- 19 Jun 2016
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Faringomoss Effectiveness in Inhibiting Acute Throat Pain and Discomfort
- ClinicalTrials.gov ID
- NCT02894372
- Acronym / sponsor ID
- Far1
- Conditions
- Spraying Behavior, Mouth Diseases, Throat Diseases, Throat Pain
- Keywords
- Oral spray, Topical sprays, Faringomoss, Local phytotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Collaborators
- Klaipėda University, Vita Longa Clinic
- Study start
- Jan 2015
- Primary completion
- 1 Nov 2016 (actual)
- Study completion
- 30 Dec 2016 (actual)
- First posted
- 9 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with oral spray 1 | Experimental | Device: Oral spray 1Research 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). |
| Subjects with oral spray 2 | Experimental | Device: Oral spray 2Research 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). |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients after throat surgeries: tonsillectomy, adenotonsillectomy, uvulopalatoplasty, uvulopalatopharyngoplasty
- Patients with acute throat diseases: pharyngitis, tonsillitis, pharyngotonsillitis
Key exclusion criteria (3 listed)
- Purulent infection
- Refusal to participate
- Allergy to tested material
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral spray 1Research participants got topical oral spray immediately after surgery (hospital patients) and from the first doctor visit with pharyngeal disease (clinic outpatients). | Device | Subjects with oral spray 1 |
| Oral spray 2Research participants got topical oral spray immediately after surgery (hospital patients) and from the first doctor visit with pharyngeal disease (clinic outpatients). | Device | Subjects with oral spray 2 |
Primary outcome
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.
4 secondary outcomes
Pharyngoscopic examination of the oropharyngeal mucosa of throat using Likert scale
Time frame: After 7 days of treatment
Secondary bleeding after surgery
Time frame: Up to 7 days
Use of medicines
Time frame: Up to 7 days
Period of time to notice the effect
Time frame: Up to 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Spraying Behavior
Recruiting
Intraperitoneal Dexamethasone Spraying on Vagal Nerve-Rich Areas for Prevention of Hoarseness After Upper Abdominal Surgery
Hoarseness, Post Operative Complicaiton
Not yet recruiting
Long-acting Spatial Emanators / Repellents (LASER)
Malaria Transmission, Malaria Prevention
RecruitingObservational study
A Study of the Efficacy and Safety of Bronchoscopic Airway Clearance and Amphotericin B Spraying in Patients With ABPA
ABPA, Allergic Bronchopulmonary Aspergillosis
Not yet recruitingPhase 4
Effect of Topical Lidocaine Spraying on the Vocal Cords Before Intubation During Robotic Surgery: a Randomized Controlled Trial
Lidocaine Spray, Intubation
Not yet recruitingPhase 2
Local Spraying of GM-CSF Via Bronchoscopy in the Treatment of Autoimmune Pulmonary Alveolar Proteinosis
Pulmonary Alveolar Proteinosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nora Siupsinskiene, Professor principal investigator
Hospital of Lithuanian University of Health Sciences, Otorhinolaryngology department
Nora Siupsinskiene, Professor principal investigator
Klaipėda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral spray 1 and Oral spray 2 in people with Spraying Behavior and Mouth Diseases, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms changes during treatment assessed using the 100 mm visual analog scale (VAS) (time frame: The first, third, fifth and seventh treatment days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2017.