A Randomized Controlled Clinical Study On Efficacy Of Amra Pallava In Navajata Kamala w.s.r. To Neonatal Jundice
试验速览
- 阶段
- 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
- The Bilirubin Level Would Be Reduced To Optimum Levels By Giving This Medicine For 5 days
研究概览
简要总结
Neonatal period extends from birth till 28 days of life.Neonatal Jaundice is found in 1st week of life.Over 2/3rd of Newborn babies develop Clinical jaundice during early days of life. Nearly 60% of term and 80% of pre-term babies are seen to be jaundiced.The yellowish discoloration of skin in Neonatal Jaundice is of great concern for parents.
Neonatal Jaundice are of two types:-Physiological Jaundice & Pathological Jaundice. Neonatal jaundice is caused by increased levels of Unconjugated Bilirubin in the blood which is toxic to the developing Central Nervous System and if left untreated, can cause Neurological Sequalae. The Increased levels of Unconjugated Bilirubin in the body can cross the blood brain barrier, thus, maintaining the levels of Bilirubin in the body within safe limits is important in order to obviate the need for Exchange Blood Transfusion.
Prophylactic Phototherapy is done (if Serum Bilirubin exceeds 12mg/dl) in several cases to prevent complications. There are certain cases of exaggerated Physiological Jaundice which may be prolonged and requires intervention.
In Ayurveda, several drugs have been mentioned for Kamala Chikitsa in children, but their role in Neonatal Jaundice, the effect on bilirubin conjugation and safety needs to be evaluated. One such drug is Amra Pallava to alleviate Kamala in children.
Though Phototherapy is considered as safe and effective modality of treatment in Neonatal Jaundice, there are few complications with Phototherapy. Thus, there is a need to find an alternative modality of treatment for Phototherapy which is safe and cost-effective.
Hence, this study is an effort in this regard to evaluate the effect of Amra pallava in Neonatal jaundice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 2.00 Day(s) 至 1.00 Month(s)（—）
- 性别
- All
入选标准
- •Name (a)Age of onset of jaundice after 2 days of birth.
- •(b)Physiological jaundice.
- •(c)Birth weight above 2000gms.
- •(d)Serum bilirubin level from 12mg/dl-16 mg/dl.
- •(e)Neonates whose parents give consent for the trial.
排除标准
- •(a)Age of onset less than 2 days of birth.
- •(b)VLBW & ELBW babies.
- •(c)Serum bilirubin level less than 12mg/dl and more than 16 mg/dl.
- •(d)All types of Pathological jaundice, Neonatal Sepsis & other systemic illness.
结局指标
主要结局
The Bilirubin Level Would Be Reduced To Optimum Levels By Giving This Medicine For 5 days
时间窗: 5 Days
次要结局
- Baby would be saved from harmful effects of Phototherapy(5 days)