A Comparative clinical Study to evaluate the effect of Yashtimadvadi and Vidaryadi medicated Milkbased Enema Therapies in The Management of Fetal Growth Restriction

A RANDOMIZED COMPARATIVE CLINICAL TRIAL ON YASHTIMADVADI AND VIDARYADI KSHEERAPAKA BASTI IN THE MANAGEMENT OF UPAVISHTAKA W.S.R. TO FETAL GROWTH RESTRICTION - nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/02/104700

Enrollment

Registered

2026-02-24

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O365- Maternal care for known or suspected poor fetal growth

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age group of 19-35 years 2. Women with known LMP 3. Singleton pregnancy with gestational age 28 weeks upto 37 weeks. 4. Both Primi and Multi gravida 5.Both Symmetrical and Asymmetrical Fetal Growth Restriction associated with or without decreased amniotic fluid. 6.Irrespective of Previous mode of delivery.

Exclusion criteria

Exclusion criteria: 1. Congenital anomalies of fetus detected through USG TIFFA Scan. 2. Pregnancy complicated with Uncontrolled Gestational diabetes and Gestational hypertension. 3. Known case of Abruptio placenta. 4. Complicated Placenta previa. 5. Severe Pre-eclampsia (BP more than 160/110mmHg, Proteinuria more than 0.3g/L). 6. History of Eclampsia. 7. Oligohydramnios (AFI less than 5). 8. Severe Anaemia (Hb lee than 7g/dl). 9. Multiple pregnancies. 10. Systemic diseases like severe forms of cardio vascular diseases renal diseases active TB HIV hepatitis B diabetes mellitius hypertension etc.

Design outcomes

Primary

Measure	Time frame
The primary outcome measure of the study as per the objective to evaluate the effect of Yashtimadvadi and Vidaryadi Ksheerapaka Basti in the management of Upavishtaka w.s.r. to Fetal Growth Restriction, will be the improvement in Estimated Fetal Weight (EFW) percentile assessed by ultrasonography. Birth weight of the baby will be recorded at the time of delivery as the final confirmatory primary outcome reflecting overall fetal growth improvementTimepoint: Day 0, Day7, Day21 and at the time of Birth	—

Measure

Time frame

The primary outcome measure of the study as per the objective to evaluate the effect of Yashtimadvadi and Vidaryadi Ksheerapaka Basti in the management of Upavishtaka w.s.r. to Fetal Growth Restriction, will be the improvement in Estimated Fetal Weight (EFW) percentile assessed by ultrasonography. Birth weight of the baby will be recorded at the time of delivery as the final confirmatory primary outcome reflecting overall fetal growth improvementTimepoint: Day 0, Day7, Day21 and at the time of Birth

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Secondary

Measure	Time frame
1.The secondary outcome measures will include improvement in Umbilical Artery Doppler parameters assessed at baseline (Day 0) and on the 21st day after intervention 2.change in Symphysis Fundal Height (SFH) measured at baseline and on the 21st day 3.improvement in Amniotic Fluid Index (AFI) assessed at baseline and on the 21st day 4.assessment of fetal movements recorded at baseline, during the 7-day intervention period, and on the 21st day.Timepoint: Day0 Day7 and Day21	—

Measure

Time frame

1.The secondary outcome measures will include improvement in Umbilical Artery Doppler parameters assessed at baseline (Day 0) and on the 21st day after intervention 2.change in Symphysis Fundal Height (SFH) measured at baseline and on the 21st day 3.improvement in Amniotic Fluid Index (AFI) assessed at baseline and on the 21st day 4.assessment of fetal movements recorded at baseline, during the 7-day intervention period, and on the 21st day.Timepoint: Day0 Day7 and Day21

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Countries

India

Contacts

Public ContactDr Aishwarya S S

Dr N A Magadum Ayurvedic Medical College and Hospital Ankali

drtejpalchandake@gmail.com8867883446

Outcome results