A Randomised comparative Clinical trial to Evaluate the Effect of Madhura Aushad siddha khanda kalpana as rasayana during 6th And 7th Month of Pregnancy w.s.r. to the maternal and Fetal Outcome
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- rasayana assessment will be based on following subjective and objective criteria i.e
研究概览
简要总结
The Present Title ’’ A Randomised Comparative Clinical Trial to Evaluate the Effect of Madhura Aushad Siddha Khanda Kalpana as Rasayana during 6th and 7th month of Pregnancy w.s.r. to the Maternal and Fetal Outcome’’ a clinical study with total number of 40 registered pregnant women with their completed 5th month of pregnancy will be selected and randomly allocated into 2 groups in each 20.
20 pregnant women completing their 5th month of pregnancy will be randomly alloted in 2 groups .
Group A will be administered with Madhura Aushad Siddha Khanda Kalpana 12gm BD with Milk
Group B will be administered with Routine Antenatal Care supplement of IRON and CALCIUM.
Assessment will be done with subjective objective criteria and investigations before and after treatment i.e 60th day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Both primi and multi gravida with completed 5th month of pregnancy.
- •Age 18years to 35 years Hb more than 8gm/dl.
排除标准
- •Pregnancy complicated with Pregnancy Induced Hypertension(PIH),Gestational Diabetic Mellitus(GDM),Amniotic Fluid Disorder Oligohydraminos or polyhydraminos,Abnormal Anomaly scan,Cervical Incompetency, FGR(fetal growth restriction),Pregnancy with Antepartum Haemorrhage.
- •Pregnancy with HB less than 8gm/dl Maternal systemic disease such as k/c/o Hypertension, Diabetes Mellitus,Thyroid Dysfunction,Thalassemia,Asthma ,Epilepsy,Cardiovascular system,Central nervous system.
- •Previous history of Intra Uterine Death(IUD),Abortion, Bad Obstetrics History, Multiple Pregnancy.
结局指标
主要结局
rasayana assessment will be based on following subjective and objective criteria i.e
时间窗: 60 days of Drug administration
subjective criteria : maternal -Tiredness, constipation,distrubed sleep,pallor,anorexia,fatigue,backache,leg cramps
时间窗: 60 days of Drug administration
objective criteria:
时间窗: 60 days of Drug administration
maternal weight,Hb%
时间窗: 60 days of Drug administration
TAS for fetal growth parameters like BPD(Biparietal Diameter,HC-head circumference), AC (abdominal circumference),FDL- (Femoral Diaphysis length), EFW-(estimated fetal weight)
时间窗: 60 days of Drug administration
次要结局
- Maternal weight(and TAS for fetal growth parameters like BPD(Biparietal diameter) ,AC (abdominal circumference), HC ( head circumference),)
研究者
Dr. Shireen Taj Patel
Dr. N.A Magadum Ayurvedic Medical College,Hospital And Research Centre,Ankali-591213