An open label randomized controlled clinical trial to evaluate the effect of dhatri lauha in the management of garbhini pandu (iron deficiency amenia)
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
- To evaluate the efficacy of dhatri lauha in garbhini pandu in change in haemoglobin level.
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 Dhatri lauha in a dose of 250mg 2 tablet twice a daily with pateble water in pregnant women from 16-18 weeks to till delivery on garbhini pandu. In one group Dhatri lauha along with calcium tablet(calcium carbonate) will be given and the other group will be given only the routine antenatal care. In Group A and B, other supplementary medicines and vaccination as per routine ANC Guidelines will be followed in Group A (without Iron tablet) and Group B. 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 Dhatri lauha on Garbhini pandu in change in Hb% level.Hb% will be noted at the time of 15th day, 20th week, 28th week, 32th week,and just before delivery. The secondary outcome measure will be to evaluate the effect of the drug on the change in hypochromic and microcytic RBCs, sign and symptoms of Garbhini pandu i.e daurbalya, hrudrava, shwasa, shoth. follow up will be on every 15th day in 4th to 6th month, every 8th day in 7th to 9th month.
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
- •pregnant women with gestational age 16-18 weeks,having Hb% equal or less than 10gm% but more than 7.5gm%.
- •Microcytic hypocromic appearance of RBC in peripheral smear.
- •pregnant women,belonging to the age group of 18 to 35 years having clinical singh and symptoms of pandu like -panduta,hrudrava,shwasa,shothas.
- •Subjects willing to participate in the study and provide signed informed consent.
排除标准
- •Pregnant women having Hb% count less than 7.5% and more than 10gm%.
- •Pregnant women comeing with pregnancy related complications like PIH,hyperemesis gravidarum,pre eclampsia,diabetes,thyroid dysfunction etc.
- •patients having high risk pregnancy.
- •megaloblastic RBCs.
结局指标
主要结局
To evaluate the efficacy of dhatri lauha in garbhini pandu in change in haemoglobin level.
时间窗: Hb% done after 15 days starting the treatment.if improved Hb% then will be continued again report 15th,20th,32th,36th,before term at the time of delivery.
次要结局
- To evaluate the efficacy of dhatri lauha in garbhini pandu in change in haemoglobin level.(Every 15th day in 4th to 6th month;every 8th day in 7th to 9th month)