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| Name | Class |
|---|---|
| KlaipÄ—da University | OTHER |
| Vita Longa Clinic | UNKNOWN |
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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.
Study objectives were:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral spray 1 | Device | Research participants got topical oral spray immediately after surgery (hospital patients) and from the first doctor visit with pharyngeal disease (clinic outpatients). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After 7 days of treatment |
| Secondary bleeding after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nora Siupsinskiene, Professor | Hospital of Lithuanian University of Health Sciences, Otorhinolaryngology department | Principal Investigator |
| Nora Siupsinskiene, Professor | KlaipÄ—da University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lithuanian University of Health Sciences | Kaunas | Lithuania |
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| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D010612 | Pharyngitis |
| ID | Term |
|---|---|
| D009057 | Stomatognathic Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
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| Oral spray 2 | Device | Research participants got topical oral spray immediately after surgery (hospital patients) and from the first doctor visit with pharyngeal disease (clinic outpatients). |
|
We note if there was a bleeding after throat surgery during investigation time. |
| Up to 7 days |
| Use of medicines | We evaluate the amount of used standardized analgesics/anti-inflammatory drugs. | 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. | Up to 7 days |
| D012140 |
| Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |