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

Phase 2

Not yet recruiting

• Conditions: Obstetrics. Ayurveda Condition: GARBINIROGAH,

• Registration Number: CTRI/2023/07/055890
• Lead Sponsor: Dr Devika Srinivasan Divakaran

Brief Summary

Pregnancy is one of the crucial phase in a woman’s life during her journey towards motherhood. As per a recent National survey study in India, it was estimated that 1.3 million Indian women have died from maternal causes over the last two decades.

Maternal health is maintained by following *Garbhini Paricharya* i.e., a systemic lifestyle and diet regimen along with various Ayurvedic formulations told in the classics. Along with *Masanumasika Pathya*, *Garbhini Paricharya* includes *Garbhasthapaka Dravyas* or drugs which are beneficial for the maintenance of Pregnancyand *Garbhopaghatakara Bhavas* which lists the factors that are harmful to the foetus and should be avoided by the pregnant woman.

*Sahasrayogam* and *Arogyakalpadruma* are two important Ayurvedic texts which have exclusive references on *Garbhini Ksheerapakas.* As per this reference, different drugs in the form of *Ksheerapaka* are advocated month-wise throughout pregnancy.

In the 7th month, *Yava Siddha Ksheerapaka* is advised as it is a good source of micro and macro-nutrients maintaining adequate *Garbha Poshana* and actively stimulates foetal development especially lungs and kidney. As it is bulk promoting it helps to relieve constipationand due to its diuretic effect, it relieves pedal oedema which is commonly seen in the third trimester.

*Morata Siddha Ksheerapaka* is told for the 8th month as it acts as *Tridosha Shamana* and has anti-bacterial properties. *Morata* is proved to act as a skeletal muscle relaxant and thereby relieves backpain due to the increasing weight of the gravid uterus.

Asthe ninth month begins, the woman enters to her *Prasava Kala. Shatavari Siddha Ksheerapaka* due to its *Madhura Rasa* and *MadhuraVipaka* acts as a good galactagogue and has immunomodulatory effect.

Hence, this study is intended to evaluate the efficacy of *Garbhini Ksheerapakas* for *Garbha Poshana* in the 7th, 8th and 9th month of pregnancy.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-07-29
• Study Start: 2023-10-08

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 30

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

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-Improvement in Subjective symptoms: Fatigue, Pedal Oedema, Backache, Heart Burn, Malapravritti, Heaviness of body (Anga Gourava)	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
-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	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
-Mode of Delivery- Normal delivery	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 Outcome Measures

Name	Time	Method
-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

Trial Locations

Locations (1)

Sri Sri College of Ayurvedic Science and Research Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Sri Sri College of Ayurvedic Science and Research Hospital

🇮🇳Bangalore, KARNATAKA, India

Dr Devika Srinivasan Divakaran

Principal investigator

8904462503

devika9797@gmail.com