Clinical Evaluation of efficacy and safety of Vaporizing Cold Rub in symptoms of cold
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in cold symptoms
研究概览
简要总结
It is a clinical study to evaluate efficacy and safety of Vaporizing Cold Rub in symptoms of cold. The study will be carried out at 1-2 center in India. Subjects will be asked to apply Vaporizing Cold Rub on the forehead, nose, sinuses, throat, and chest and take steam inhalation three times daily for 7 Days. The primary objective of the study will be to assess cold symptoms. Secondary objectives of the study will be to assess number of subjects completely relieved from cold symptoms, sleep quality satisfaction requirement for rescue medications, skin patch tests global assessments of overall change as assessed participant and physician, adverse events and drug reactions including vital signs on Baseline Visit, Visit1 (24hrs), Visit 2 (48hrs), Visit 3 (Day 3), Visit 4 (Day 7)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 4.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinically diagnosed with common cold
- •Beginning of the symptoms of common cold in a minimum period of 24 hours and a maximum of 72 hours prior to baseline visit;
- •Willing to comply with all requirements of the study.
排除标准
- •Presence of significant septum deviation, compatible with impaired nasal ventilatory function, at the investigators discretion.
- •Presence of nasal polyposis to previous rhinoscopy.
- •Required antibiotic therapy for upper airway infection treatment
- •Subjects on any other investigational products within 1 month prior to randomization
- •Subjects with known current tuberculosis, HIV, ischemic heart disease, cancer, kidney failure, liver failure
- •Any medical conditions which may interfere with efficacy and or safety of the treatment with the investigational product
- •Pregnant and lactating women
- •Known hypersensitivity to any of the ingredients of Vaporizing Cold Rub
- •Other conditions, which in the opinion of the investigators, make patient unsuitable for enrolment or could interfere with his or her participation in, and completion of the study.
结局指标
主要结局
Change in cold symptoms
时间窗: Baseline Visit, Visit1 (24hrs), Visit 2 (48hrs), Visit 3 (Day 3), Visit 4 (Day 7)
次要结局
- 1. Number of subjects relieved completely from symptoms of cold(2. Satisfaction of the quality of sleep)
研究者
Dr Priyanka Patil
Shree Sai Clinic