NCT03369132Unknown不适用
Efficacy of Natural Seawater Based Throat Spray in Acute Sore Throat Relief: a Prospective, Randomized, Double-blind, Placebo-controlled, Multicentre Clinical Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 360
- 试验地点
- 32
- 主要终点
- Sore Throat Relief
研究概览
简要总结
Prospective, randomized, double-blind, placebo-controlled, multicentre clinical trial to assess the efficacy and tolerability of natural seawater based throat spray among adult patients with acute sore throat.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (male or female) aged ≥ 18 years old.
- •Patients with complaint of sore throat ≤ 72h.
- •Sore throat exclusively due to upper respiratory tract infection (tonsillitis, pharyngitis, rhinopharyngitis).
- •Clinical confirmation by the physician for the presence of typical signs (spontaneous pain, local inflammation) of acute pharyngitis or tonsillitis.
- •Pain intensity scored by patient on the 5-point descriptive pain intensity scale as slight, mild or moderate.
- •Willingness to provide written informed consent prior to perform of any study related procedure.
- •Subjects agreeing to follow the study requirements during the whole study period (including forbidden medication and food supplements).
- •Subjects agreeing not to modify their lifestyle habits during the whole study period (diet, physical activity).
- •Subject affiliated to social security.
- •Subject able to understand verbal and written local language and in capacity to fill-in patient diary by himself/herself.
排除标准
- •Previous history of allergy or known intolerance to one of the following formulation ingredients: seawater, vegetable glycerin, mint, lemon, acacia honey, propolis, essential oils.
- •Active Smokers.
- •Fever > 38°C at randomization.
- •Past or current throat phlegmon.
- •Past or current seasonal allergy.
- •Past or current asthma.
- •Past or current chronic rhinosinusitis.
- •Past or current chronic obstructive pulmonary disease (COPD).
- •Past or current ENT (Ear, Nose and Throat) cancer.
- •Acute rhinosinusitis.
- •Controlled or uncontrolled diabetes.
- •Gastroesophageal reflux disease (GERD).
- •Known immunodeficiency.
- •Any painful condition that may distract attention from sore throat pain (ex: mouth ulcers etc.) or that requires analgesic usage.
- •Any disease that may interfere with the study aim from investigator's opinion.
- •Evidence of mouth breathing or severe coughing.
- •Patient with severe pain intensity on 5-point descriptive pain intensity scale.
- •Subjects taking:
- •chronic treatment for throat or other ENT pathology,
- •current antibiotherapy or stopped less than 2 weeks before inclusion,
- •chronic treatment (>3 months) with local or systemic corticotherapy, or immunotherapy,
- •local or systemic antihistaminic.
- •Subjects refusing to stop at entry into the study:
- •throat spray, lozenge, pastille,
- •local throat or systemic analgesic,
- •medicated confectionary,
- •nasal wash and spray,
- •nasal corticosteroid or antihistaminic nasal spray,
- •medication to gargle,
- •honey, propolis, or any sore throat home remedies.
- •Known liver disease or hypersensitivity to paracetamol.
- •Pregnant, breastfeeding or seeking pregnancy women.
- •Positive result from rapid strep throat test.
- •Subjects already included once in this study.
- •Subjects participating in another clinical trial or in the exclusion period to another study.
- •Subjects having a member of his/her home who is currently participating to this study.
研究组 & 干预措施
Angiflash
Experimental
干预措施: Angiflash (Device)
Placebo
Placebo Comparator
干预措施: Placebo (Device)
结局指标
主要结局
Sore Throat Relief
时间窗: Over the first three days
Evaluation of sore throat relief using the 7-point sore throat relief scale (STRS)
次要结局
- Product Satisfaction(Day 8)
- Sore Throat Pain Intensity(Day 1, 2, 3, 4, 5, 5, 7 to 8.)
- Difficulty Swallowing(Day 1, 2, 3, 4, 5, 5, 7 to 8.)
- Overall efficacy assessed by the physician(Day 8)
- Incidence of adverse events occuring during the study(Day 1, 2, 3, 4, 5, 5, 7 to 8.)
- Sore Throat Individual Symptoms Relief(Day 1, 2, 3, 4, 5, 5, 7 to 8.)
- Swollen Throat(Day 1, 2, 3, 4, 5, 5, 7 to 8.)
- Compliance: assessment of the number of use per day and the number of spray per use(Day 1, 2, 3, 4, 5, 5, 7 to 8.)
研究者
研究点 (32)
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