CTRI/2026/02/103227 [Registered on: 06/02/2026] Trial Registered Prospectively
Last Modified On:
05/02/2026
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Ayurveda Other (Specify)
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
to study the Effect of Gokshursiddha ghrit will be check in assymetrical intrauterine growth retarded fetus in pregnant woman.
Scientific Title of Study
The study of the effectiveness of Gokshursiddha ghrit in vatabhippana shushka garbha
with special reference to assymetrical IUGR INTRAUTERINE GROWTH RESTRICTION
Trial Acronym
Nil
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
opd no 1, department streerog prasuti Dr G.D.Pol Foundation , Y.M.T.Ayurvedic Medical College,And Hospital , P.G.Institute , Kharghar , Navi Mumbai , 10 opd no 1 . department - streerog prasuti Dr G.D.Pol Foundation , Y.M.T.Ayurvedic Medical College,And Hospital , P.G.Institute , Kharghar , Navi Mumbai , 10 Mumbai (Suburban) MAHARASHTRA 410210 India
Phone
8007211418
Fax
Email
drtruptkale80@gmail.com
Source of Monetary or Material Support
Dr G.D.Pol Foundation , Y.M.T.Ayurvedic Medical College,And Hospital , P.G.Institute , Kharghar , Navi Mumbai , 10
L Arginine powder 5 gm with 100 ml of water once a day after meal for 6 weeks
Inclusion Criteria
Age From
20.00 Year(s)
Age To
35.00 Year(s)
Gender
Female
Details
Voluntary participants ANC patients with GA 28-30 weeks
Singleton pregnancy
Mild asyymetrical IUGR with normal AFI
Primipara as well as multipara
Age between 20-35 years
With normal anomaly scan report
Coin toss, Lottery, toss of dice, shuffling cards etc
Method of Concealment
Alternation
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Adequate fetal growth
Baseline - after 2, 4, 6 weeks
Secondary Outcome
Outcome
TimePoints
To study the number of patients having IUGR in relation to parity.
To study the disease according to etiological factors.
To study the effect of Gokshur on apara (placenta ).,garbh, garbhini.
To study the drug Gokshur & its properties (Brihan) from Ayurvedic literatures
To reduce peri-natal morbidity & mortality due to Vatabhipanna shushka garbha
To study the clinical diagnosis of IUGR, ultrasound findings of IUGR
To study the association between IUGR & nature of delivery
Baseline - after 2 , 4 , 6 weeks
Target Sample Size
Total Sample Size="120" Sample Size from India="120" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 2/ Phase 3
Date of First Enrollment (India)
22/02/2026
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="3" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Yet Recruiting
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Life starts from the conception.
Intra uterine life has developmental origin of
health and many disease.
The commonest problem fetusin intrauterine life is unable to reach its
growth potential, if the estimated fetal weight is less than 10th percentile
of the expected weight, which is called as Intrauterine growth restriction
(IUGR).
Intrauterine growth restriction not
only affectes physical growthof the
fetus buta mental and cognitive
function is also affected.
Intrauterine growth restriction is
a common public health problem. 10-15% pregnancies are affectedworldwide.out of total IUGRcases 70-80% caese
are of assymetrical IUGR.
50% perinatal deaths are due to
IUGR.
After prematurity it is the second
leading cause of perinatal morbidity and mortality.
Prenatal mortality rate is4-8 times higher inIUGR fetuses.
In garbhani her ahar rasa is
devided into three partsfor
1 Garbhposhan
2 Stanyavruddhi
3 Matru poshan .
Vata dosha plays very important role in
garbhposhan, due to mithya ahar,vihar vata dosha gets vitiated causes
vatabhipanna shushka garbha.
To treat this Shushka garbhaone has to do brihan chikitsa .
We can corelate vatabhipanna
shushka garbh withasymmetrical IUGR (Intrauterine
growth restriction).
David Barker had discovered the
relation between the lower birth weight and the higher prevalence of ischemic
heart disease mortality
“Barker’s
hypothesis” emerged almost 25 years ago from epidemiological studies of birth
and death records that revealed a high geographic correlation between rates of
infant mortality and certain classes of later adult deaths as well as an
association between birthweight and rates of adult death from ischemic heart
disease. These observations led to a theory that undernutrition during
gestation was an important early origin of adult cardiac and metabolic
disorders due to fetal programming that permanently shaped the body’s
structure, function, and metabolism and contributed to adult disease. This
theory stimulated interest in the fetal origins of adult disorders, which
expanded and coalesced ~5 years ago with the formation of an international
society for developmental origins of health and disease (DOHaD)
IUGR happens because the fetus doesn’t get enough
nutrients and nourishment. This can happen if there is a problem with: the
placenta, the tissue that brings nutrients and oxygen to the developing baby
the blood flow in the umbilical cord, which connects the baby to the placenta
Intrauterine growth restriction also can happen if a
pregnant woman:
smokes, drinks alcohol, or uses drugs
has an infection, such as cytomegalovirus, German
measles (rubella), toxoplasmosis, or syphilis
takes some types of medicines, such as some seizure
treatments
has a medical condition such as lupus, anemia, or
clotting problems
has high blood pressure (hypertension)
is carrying a baby that has a genetic disorder or
birth defect
is pregnant with multiples
Complications of
IUGR
problems with breathing and feeding
trouble keeping a steady body temperature
abnormal blood cell counts
low blood sugar level (hypoglycemia)
problems
fighting off infections
RATIONAL OF STUDY
Every month there are 5-6 anc
mothers with growth scan 28 weeks diagnosed as assymetrical IUGR.
There is still lack of awareness
about own health as well as fetal health .
Untreated and undiagnosed iugr
cases increases perinatal mortality,contributes many diseases in adult life.
Perinatalmortality and morbidity ismostly
due to IUGR fetuses.
There is no any specific drug for
IUGR other than l arginine.
Ayurveda stated many drugs forgarbh -garbhini brihin chikitsa .
Evidence based research is neded to
apply these drugs to the population.