NCT00552773已完成不适用
A Randomized, Double-blind, Placebo Controlled, Parallel Group Trial of Cyclamen Europaeum Extract Nasal Spray 10% (v/v) in the Treatment of Subjects With Acute Sinusitis
Dey25 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2007年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 25
- 主要终点
- Subjective: The mean change in Total Symptom Score (TSS). Objective: The mean change in the percent of sinus occlusion as determined by CT scans.
研究概览
简要总结
To evaluate the efficacy and safety of Cyclamen europaeum extract 10 % (v/v) compared to placebo in subjects with acute sinusitis
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults age 18-70
- •Must be symptomatic on the basis of subject assessments of total sympton score.
- •Evidence of mucopurulence on nasal endoscopy
- •Evidence of inflammation upon nasal endoscopy
- •CT scan with radiographic signs of acute sinusitis
- •Able to complete all study activities or procedures through the end of the study, including all visits and tests, and capable of selfadministration of study medication
- •Agree to abide by the study protocol and its restrictions
排除标准
- •Known history of hypogammaglobulinemia, immotile cilia syndrome, atrophic rhinitis, rhinitis medicamentosa, or cystic fibrosis
- •Known hypersensitivity to Cyclamen, Primula, or other Primulaceae
- •Serious unstable comorbidity such as malignancy (other than squamous or basal cell carcinoma of the skin) or sever renal or hepatic disease.
- •Abnormal screening laboratory/imaging test results
- •Condition(s) that compromise the ability to either administer the agent or assess the risks/benefits (eg mucocele, choanal polyp, Stage 4 polyposis or cyst extending below the inferior turbinate, deviated septum, facial trauma, or birth defect)
- •Expansile mass or bony erosion on sinus radiograph
- •Females who are pregnant, planning to become pregnant or currently breastfeeding.
- •History of viral upper respiratory infection (URI) in the past 2 weeks
- •Temperature greater than 102.5°F
- •Facial or periorbital edema
- •Local complications including orbital cellulitis; acute abnormalities of extraocular movements; cavernous vein thrombosis; dental or facial abscess
- •Altered mental status
- •Recent nasal or sinus surgery (within 3 months or less) or planned surgery within the next 3 months
- •Use of intranasal antibiotics within the previous 30 days or systemic antibiotics within the previous 15 days
- •Use of oral and/or topical nasal decongestants within the previous 7 days
- •Had radiation therapy or chemotherapy within the previous 12 months
- •Have used an investigational drug or device within 30 days prior to screening
- •Have a history of illegal drug or alcohol abuse within the past 5 years
- •Have major unstable organ system disease that could place the subject at increased risk of complications, interfere with study participation, or confound any of the study objectives Subjects who have asthma, seasonal and/or perennial allergic rhinitis will be allowed to enter the study.
研究组 & 干预措施
Cyclamen Europaeum
Experimental
干预措施: Cyclamen Europaeum (Drug)
Placebo
Placebo Comparator
干预措施: Cyclamen Europaeum (Drug)
结局指标
主要结局
Subjective: The mean change in Total Symptom Score (TSS). Objective: The mean change in the percent of sinus occlusion as determined by CT scans.
时间窗: 1 year
次要结局
- TSS change from Baseline to each post-dose visit for each symptom scoring Change from Baseline for the individual symptom scores Time to cure rate Frequency of acute sinusitis episodes The presence/absence of mucopurulence and inflamed nasal mucosa(1 year)
研究者
研究点 (25)
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