Efficacy of Ajamoda Arka with Yava Kshara in the Management of Vataja Udarashoola, Infantile Colic
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1)Reduction in the clinical features of Vataja udara shoola.
研究概览
简要总结
A open labelled randomized controlled clinical trial on the efficacy of Ajamoda arka with Yava kshara in the management of Vataja Udarshoola, Infantile colic in infants of age group 1 to 5 months.during this study period, 50 childrens will be recruited and divided into 2 groups, Group A(trial group) and Group B(control group),25 in each group. Group A(trial group) infants will be adminstered ajamoda arka with yavakshara (for the age of 1 to 3 month 0.5 ml TID with 1 ml takra(anupana) and for the age of 4 to 5 months 1ml TID with 2ml anupana takra)and Group B (Control group) infants will be adminstered shatapushpa arka (for the age of 1 to 3 months,0.5ml TID and for 4 to 5 months 1ml TID) for a period of 15 days. Clinical assesement will be done for both subjective and objective criteria on 0th day, 7th day and 16th day. Follow up on 21st day. Statistical anylysis will be done through data collected on 0th day and 16th day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 1.00 Month(s) 至 5.00 Month(s)（—）
- 性别
- All
入选标准
- •1.Infants of either gender diagnosed with infantile colic as per ROME IV criteria 2.Infants aged 1 month to 5 months 3.Infants with recurrent and prolonged periods of crying, fussiness or irritability as reported by care givers that occur without any apparent cause and cannot be prevented or consoled by care givers 4.Full term healthy neonates 5.Mothers and care givers who are willing to participate and ready to give written consent.
排除标准
- •1.Infants with disorder of bowel or urinary tract disorders that might present as abdominal distension, inguinal swelling or scrotal swelling.
- •2.Infants with chronic or acute systemic illnesses of gastrointestinal, Respiratory etc.
- •3.Infants with known cases of chromosomal, metabolic and hereditary Disorders.
- •4.Infants or their who are on medication or diet that may interfere with study objectives.
- •5.Breast feeding mothers or their kids on antibiotic therapy in the last 15 days.
- •6.Mothers who consume alcohol, smoke and tobacco.
- •7.Infants who are on formula feed or animal(feed) milk.
结局指标
主要结局
1)Reduction in the clinical features of Vataja udara shoola.
时间窗: Baseline, 15 Days
2)Reduction in the Intensity of cry & fussing by FUSSINESS rating scale.
时间窗: Baseline, 15 Days
次要结局
- 1) Decrease in Pain, improvement in activity and sleep behaviour based on FLACC scale.(2) Improvement in the Gastro intestinal features- IGSQ score.)
研究者
Dr Tale Vaibhav Vitthalrao
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bangalore