Scope of Homoeopathy as an add-on therapy in improvement of functional parameters in Pre-term neonates under standard management in Neonatal Intensive Care Unit(NICU): A single-blind randomized control trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Improvement in specific functional parameters—namely respiratory rate, weight gain, and feeding efficiency—in preterm neonates receiving Homoeopathy as an add-on therapy alongside standard NICU care, compared to those receiving standard NICU care alone.
研究概览
简要总结
In this single-blind, randomized, placebo-controlled experimental study, the aim is to evaluate the Scope or effectiveness of Homoeopathy as an add-on therapy in improving functional parameters in preterm neonates receiving standard NICU care. Eligible neonates will be randomly assigned to either the experimental group (receiving Homoeopathic intervention) or the control group (receiving placebo), alongside standard NICU treatment. Functional outcomes such as respiratory rate, weight gain, and feeding efficiency will be assessed and compared between groups. Statistical analysis will be conducted to determine the significance of observed differences, and the null or alternate hypothesis will be accepted or rejected accordingly.
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
- 0.00 Day(s) 至 28.00 Day(s)（—）
- 性别
- All
入选标准
- •Pre-term neonates (born before 37 weeks of gestation) of more than 28 weeks of gestational age.
- •Admitted to the NICU and receiving standard NICU management care under the neonatologist.
排除标准
- •Neonates with severe congenital anomalies or genetic disorders who require immediate surgical/ cardiac interventions at higher centers.
- •Neonates with life-threatening conditions where immediate intensive care and referral to higher centers are required.
- •Neonates of gestational age less than 28 weeks (extremely preterm neonates).
结局指标
主要结局
Improvement in specific functional parameters—namely respiratory rate, weight gain, and feeding efficiency—in preterm neonates receiving Homoeopathy as an add-on therapy alongside standard NICU care, compared to those receiving standard NICU care alone.
时间窗: Baseline, day 2, Day 3, day 4, week 2, week 3, discharge and 1st follow up
次要结局
- 1. Evaluation of the broader scope of Homoeopathy in enhancing functional health indicators in preterm neonates when used as an adjunct to conventional NICU management.(2. Comparison of morbidity & mortality rates between neonates receiving standard NICU care & those receiving additional Homoeopathic treatment.)
研究者
Dr Nikita Sureshchandra Mehta
Dr M L Dhawale Memorial Homoeopathic Institute