Clinical Study to Evaluate Efficacy and Safety of Menthoplus Soft balm in subjects suffering symptoms of cold.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
It is a clinical study to evaluate efficacy and safety of Menthoplus Soft balm in subjects suffering symptoms of cold. The study will be carried out at one center in India. Subjects will be asked to apply Menthoplus Soft balm on forehead, nose, paranasal sinuses area, throat and chest three times daily for 7 days. Also, subjects will be asked to take steam inhalation using Menthoplus Soft balm thrice daily for 7 days. The primary objective of the study will be to assess change in cold symptoms nasal block, cough, headache, sore throat, runny nose, body ache, chills. The secondary objectives of the study will be to assess number of subjects relieved completely from symptoms of cold, headache on VAS, onset of action, duration of action, and relief period of cold symptoms and headache, onset of action, duration of action of counter-irritancy and cooling effects, satisfaction of the quality of sleep, requirement of rescue medications, skin patch test using Dermal Response Score, global assessment for overall change by participants and by physician and adverse events, adverse drug reactions including vitals on Day 0, Day 3 and 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
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Clinically diagnosed with common cold defined by clinical evaluation and presence of at least two or more of the following symptoms nasal block, cough, headache, sore throat, runny nose, body-ache, chills classified as moderate to severe category
- •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
- 未提供
研究者
Dr Priyanka Patil
Target Institute of Medical Education and Research Pvt Ltd
