Faringomoss Effectiveness in Inhibiting Acute Throat Pain and Discomfort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Symptoms changes during treatment assessed using the 100 mm visual analog scale (VAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients after throat surgeries: tonsillectomy, adenotonsillectomy, uvulopalatoplasty, uvulopalatopharyngoplasty
- •Patients with acute throat diseases: pharyngitis, tonsillitis, pharyngotonsillitis
排除标准
- •Purulent infection
- •Refusal to participate
- •Allergy to tested material
结局指标
主要结局
Symptoms changes during treatment assessed using the 100 mm visual analog scale (VAS)
时间窗: 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.
次要结局
- Secondary bleeding after surgery(Up to 7 days)
- Period of time to notice the effect(Up to 7 days)
- Use of medicines(Up to 7 days)
- Pharyngoscopic examination of the oropharyngeal mucosa of throat using Likert scale(After 7 days of treatment)
研究者
Nora Siupsinskiene
Professor, Doctor of Medicine and Doctor of Philosophy (PhD)
Lithuanian University of Health Sciences