Clinical Trial Unicenter, Phase III, Randomized, Double-blind, Comparative to Evaluate the Efficacy, Tolerability and Superiority of Luffa Operculate Nasal Solution 5mg/mL Compared With Saline Solution in the Relief of Nasal Obstruction.
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Improvement of nasal congestion
研究概览
简要总结
Sixty subjects will take part in this study. The subjects will be randomly assigned in a 1:1 ratio between the two arms of study. (Group A: Solution of Luffa Nasal Operculate 5mg/mL, Group B: saline).
The subjects will use the study medication or comparative, according to their randomization, for a treatment period of 3 to 7 days. A follow-up visit will be made 15 days after initiation of treatment.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects of both sexes aged over 18 years.
- •Presence of nasal congestion due to colds, rhinitis, influenza, sinusitis and acute or chronic sinusitis
- •Sign the Informed Consent Form
- •Comply the study requirements and attend to study visits
- •Female subjects must have a NEGATIVE urine pregnancy test during the screening.
排除标准
- •Known allergy to any study product component
- •Subject pregnant, lactating or of childbearing potential and not using adequate and effective contraceptive
- •Vasoconstrictor nasal topic or oral
- •Use of a decongestant nasal whatever the route of administration
- •Use of intranasal corticosteroids
- •Use of antiallergic
- •Use of medication containing atropine
- •Subjects that are participating in another study or who participated in another study, less than 12 months
- •Any subjects deemed unsuitable for study by the Principal Investigator
- •Abuse of alcohol or illicit drugs
研究组 & 干预措施
Luffa Operculate Nasal Solution 5mg/mL
The treatment will start on the first visit in which subjects will be instructed to instill in the nasal passages, 3 drops of the product by morning and 3 drops of the product at night.
干预措施: Luffa Operculate Nasal Solution 5mg/mL (Drug)
Saline Solution (NaCl 0,9%)
The treatment will start on the first visit in which subjects will be instructed to instill in the nasal passages, 3 drops of the product by morning and 3 drops of the product at night.
干预措施: Saline Solution (NaCl 0,9%) (Drug)
结局指标
主要结局
Improvement of nasal congestion
时间窗: 3 days
If the patient present a improvement of nasal congestion 3 days after the treatment start, the treatment will be discontinued and the patient will perfomr the Visit 2.
次要结局
未报告次要终点