A study to evaluate the effect of Garbhini Ksheerakashayas for maternal and fetal nourishment in 7th 8th and 9th month of pregnancy

A Randomized open-labelled controlled clinical study to evaluate the efficacy of Garbhini Ksheerapakas for Garbha Poshana in 7th, 8th & 9th month of pregnancy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/07/055890

Enrollment

Registered

2023-07-31

Start date

Unknown

Completion date

Unknown

Last updated

2023-08-21

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

Conditions

Health Condition 1: 1- Obstetrics

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1) Primigravida and Multigravida 2) Subjects who have just completed 24 weeks of gestational age. 3) Subjects having haemoglobin value of 10 g/dL or more. 4) Subjects who are willing to give written consent for the study.

Exclusion criteria

Exclusion criteria: 1) Subjects up to 24 weeks of gestational age. 2) Systemic diseases like Hypertension, Diabetes Mellitus, Severe Anaemia, Thyroid disorders. 3) High risk pregnancies like Pre-eclampsia, Gestational Diabetes, Ante-partum Haemorrhage, Polyhydramnios.

Design outcomes

Primary

Measure	Time frame
-Improvement in Subjective symptoms: Fatigue, Pedal Oedema, Backache, Heart Burn, Malapravritti, Heaviness of body (Anga Gourava) -Improvement in Objective parameters: Haemoglobin (g/dL), Maternal Weight Gain (kg),Fundal Height (cm), Abdominal Circumference (cm), Foetal Weight (g), USG findings: Femur length, Abdominal Circumference, Head Circumference, Amniotic fluid Index -Mode of Delivery- Normal delivery Timepoint: Pre-test Assessment- 0th Day (Before 28 weeks) 1st Assessment- After completion of 28 weeks 2nd Assessment- After completion of 30 weeks 3rd Assessment- After completion of 32 weeks 4th Assessment- After completion of 34 weeks 5th Assessment- After completion of 36 weeks 1st Follow up- Weekly once till delivery after 36 weeks 2nd Follow up- At the time of Delivery 3rd Follow up- 7 days post delivery	—

Measure

Time frame

-Improvement in Subjective symptoms: Fatigue, Pedal Oedema, Backache, Heart Burn, Malapravritti, Heaviness of body (Anga Gourava) -Improvement in Objective parameters: Haemoglobin (g/dL), Maternal Weight Gain (kg),Fundal Height (cm), Abdominal Circumference (cm), Foetal Weight (g), USG findings: Femur length, Abdominal Circumference, Head Circumference, Amniotic fluid Index -Mode of Delivery- Normal delivery Timepoint: Pre-test Assessment- 0th Day (Before 28 weeks) 1st Assessment- After completion of 28 weeks 2nd Assessment- After completion of 30 weeks 3rd Assessment- After completion of 32 weeks 4th Assessment- After completion of 34 weeks 5th Assessment- After completion of 36 weeks 1st Follow up- Weekly once till delivery after 36 weeks 2nd Follow up- At the time of Delivery 3rd Follow up- 7 days post delivery

—

Secondary

Measure	Time frame
-Improvement in Objective parameters: Haemoglobin (g/dL), Maternal Weight Gain (kg),Fundal Height (cm), Abdominal Circumference (cm), Foetal Weight (g), USG findings: Femur length, Abdominal Circumference, Head Circumference, Amniotic fluid Index -Mode of Delivery- Normal deliveryTimepoint: Pre-test Assessment- 0th Day (Before 28 weeks) 1st Assessment- 30th week 2nd Assessment- 36th week 3rd Assessment- After Delivery	—

Measure

Time frame

-Improvement in Objective parameters: Haemoglobin (g/dL), Maternal Weight Gain (kg),Fundal Height (cm), Abdominal Circumference (cm), Foetal Weight (g), USG findings: Femur length, Abdominal Circumference, Head Circumference, Amniotic fluid Index -Mode of Delivery- Normal deliveryTimepoint: Pre-test Assessment- 0th Day (Before 28 weeks) 1st Assessment- 30th week 2nd Assessment- 36th week 3rd Assessment- After Delivery

—

Countries

India

Contacts

Public ContactDr Devika Srinivasan Divakaran

Sri Sri College of Ayurvedic Science and Research

dr.rachanabhat@gmail.com9535744077

Outcome results