An open label randomized controlled clinical trial to evaluate the effect of Shatavari ghrita during pregnancy on fetal outcome w.s.r. to birth weight
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Evaluate the effect of oral administration of Shatavari ghrita during pregnancy on fetal outcome w.s.r. to birth weight
研究概览
简要总结
This is an open label randomized controlled clinical trial to evaluate the effect of oral administration of Shatavari ghrita in a dose of 10 ml twice daily in pregnant women from 12 weeks onwards to 34 weeks on fetal outcome w.s.r. to birth weight.In one group shatavari ghrita will be given alongwith routine antenatal care and the other group will be given only the routine antenatal care. The study will be conducted in All India Institute Of Ayurveda, New Delhi, India. The primary outcome measure will be to evaluate the effect of Shatavari ghrita on fetal outcome w.s.r. to birth weight. Birth weight will be noted at the time of delivery and on 10th day after delivery. The secondary outcome measure will be to evaluate the effect of Shatavari ghrita in garbhini i.e. to minimize the complications of pregnancy. Follow up will be on every 15th day in 4th to 6th month and every 8th day in 7th to 9th month.Gestational age at the time of labour, mode of delivery and duration of labour will also be noted down.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Primi and second gravida with gestational age 12 to 14 weeks;able and willing to participate and provide signed informed consent.
排除标准
- •Severe anaemia Hb <7 gm/dl; pregnancy complicated by placenta praevia, coexisting fibroid, any malignancy,twins; pregnancy complicated with diseases such as hypo or hyperthyroidism, cardiovascular diseases, diabetes.
结局指标
主要结局
Evaluate the effect of oral administration of Shatavari ghrita during pregnancy on fetal outcome w.s.r. to birth weight
时间窗: Baby fetal weight by USG; Birth weight will be noted at the time of delivery and on 10th after delivery; APGAR score
次要结局
- Evaluate the effect of oral administration of Shatavari ghrita in garbhini i.e. to minimize the complications of pregnancy(Every 15th day in 4th to 6th month;every 8th day in 7th to 9th month; Gestational age at the time of labour; Mode of delivery; Duration of labour)