A clinical trial to evaluate the effect of Shatavari ghrita on fetal outcome w.s.r. to birth weight

Phase 2

Not yet recruiting

Conditions: primi and second gravida with gestational age 12-14 weeks onwards to 34 weeks

Registration Number: CTRI/2020/02/023448

Lead Sponsor: All India Institute Of Ayurveda

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 30

Inclusion Criteria

Primi and second gravida with gestational age 12 to 14 weeks;able and willing to participate and provide signed informed consent.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the effect of oral administration of Shatavari ghrita during pregnancy on fetal outcome w.s.r. to birth weight	Baby fetal weight by USG; Birth weight will be noted at the time of delivery and on 10th after delivery; APGAR score

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1): All India Institute Of Ayurveda
🇮🇳
South, DELHI, India
All India Institute Of Ayurveda
🇮🇳South, DELHI, India
Nidhi Tahlan
Principal investigator
9953051714
tahlan.nidhi@gmail.com