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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

Tracking Information
First Submitted Date  ICMJE June 19, 2016
First Posted Date  ICMJE September 9, 2016
Last Update Posted Date March 13, 2017
Study Start Date  ICMJE January 2015
Actual Primary Completion Date November 1, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02894372 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2017)
  • 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.
  • Secondary bleeding after surgery [ Time Frame: Up to 7 days ]
    We note if there was a bleeding after throat surgery during investigation time.
  • Use of medicines [ Time Frame: Up to 7 days ]
    We evaluate the amount of used standardized analgesics/anti-inflammatory drugs.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2016)
  • 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.
  • Secondary bleeding after surgery [ Time Frame: Up to 7 days ]
    We note if there was a bleeding after throat surgery during investigation time.
  • Use of medicines [ Time Frame: Up to 7 days ]
    We evaluate the amount of used standardized analgesics/anti-inflammatory drugs.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Faringomoss Effectiveness in Inhibiting Acute Throat Pain and Discomfort
Official Title  ICMJE Faringomoss Effectiveness in Inhibiting Acute Throat Pain and Discomfort
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Spraying Behavior
  • Mouth Diseases
  • Throat Diseases
  • Throat Pain
Intervention  ICMJE
  • 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).
  • 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).
Study Arms  ICMJE
  • 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).
    Intervention: Device: Oral spray 1
  • 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).
    Intervention: Device: Oral spray 2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 8, 2017)
96
Original Estimated Enrollment  ICMJE
 (submitted: September 4, 2016)
80
Actual Study Completion Date  ICMJE December 30, 2016
Actual Primary Completion Date November 1, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Lithuania
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02894372
Other Study ID Numbers  ICMJE Far1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Nora Siupsinskiene, Lithuanian University of Health Sciences
Study Sponsor  ICMJE Lithuanian University of Health Sciences
Collaborators  ICMJE
  • Klaipėda University
  • Vita Longa Clinic
Investigators  ICMJE
Principal Investigator: Nora Siupsinskiene, Professor Hospital of Lithuanian University of Health Sciences, Otorhinolaryngology department
Principal Investigator: Nora Siupsinskiene, Professor Klaipėda University
PRS Account Lithuanian University of Health Sciences
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP