An Open Label, Single Arm Clinical Trial on Effectiveness and Safety of Caspa - A Herbal Carminative, Anti-spasmodic Drops in Infantile Abdominal Colic in Children between 2 to 24 months of age
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1 Reduction in colic
研究概览
简要总结
This study is a open label, single arm clinical trial assessing the effectiveness of CaspaHerbal Carminative And Anti-Spasmodic Drops
Caspa Herbal CarminativeAnd Anti-Spasmodic Drops (i) 10drops (approx. 0.5 mL), 4 times a day, 15 minutes before feed, orally inInfants between 2 to 12 months for 42 days (ii) 20 drops (approx. 1 mL), 4 times a day,15 minutes before feed, orally Young children between 13 months to 24 months: for6 weeks in total 110 patients thatwill be conducted in one centre (SDM College of Ayurveda & Hospital,Hassan, Karnataka) in India. The primary outcome measures will be the signs andsymptoms of infantile abdominal colic at 6 weeks. The secondary outcome measureswill be patient’s quality of life and adverse drug reaction at 6 weeks.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2.00 Month(s) 至 24.00 Month(s)（—）
- 性别
- All
入选标准
- •Infants with Infantile colic and whose parents willing to give consent to participate in the study.
排除标准
- •Infants and young children suffering from acute illness.
结局指标
主要结局
1 Reduction in colic
时间窗: 6 weeks
2 Improvement in Appetite
时间窗: 6 weeks
3 Improvement in Digestion
时间窗: 6 weeks
4 Reduction in flatulance
时间窗: 6 weeks
5 Bowel activity
时间窗: 6 weeks
6 Improvement in General health
时间窗: 6 weeks
7 Weight gain
时间窗: 6 weeks
次要结局
- Assessment of drug safety(6 weeks)