Phase I Clinical Trial for Safety Assessment of an Innovative, Commercially Viable and Eco-Friendly Mosquitocidal Fumigant in Healthy Human Volunteers
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1. Assessing the safety of the herbal fumigant
研究概览
简要总结
A fumigant was prepared by using betel nut husk and natural binder and formulated into a cylindrical shaped product. This product upon ignition effuses fumes which are rich in phytoconstituents effective against different species of mosquitoes. After testing the efficacy in the mosquitoes and the pre-clinical trial in animal model, the present study is taken up to assess the safety and acceptability in healthy human volunteers.
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 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy volunteers male and female, of the age group 18 to 45 years.
排除标准
- •Pregnant or lactating women.
- •Allergy or sensitivity to fumigants or similar compounds.
- •Recent participation in another clinical trial.
- •Smoking, alcohol, or substance abuse.
- •Those on any medication.
结局指标
主要结局
1. Assessing the safety of the herbal fumigant
时间窗: Analysis will be performed at 0 to 14 days of exposure to the herbal fumigant for different time intervals, i.e., 1hr, 2hr and 3hr.
2. Acceptance of the herbal fumigant in comparison to marketed product
时间窗: Analysis will be performed at 0 to 14 days of exposure to the herbal fumigant for different time intervals, i.e., 1hr, 2hr and 3hr.
次要结局
- The following blood parameters will be checked:(1. Haemoglobin)
研究者
Mythili Krishna Jeedigunta
Goa College of Pharmacy