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CTRI Number  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)  
Name  Dr Trupti Jaideep kale  
Designation  PhD Scholar  
Affiliation  Y.M.T.Ayurvedic Medical College,And Hospital , P.G.Institute , Kharghar , Navi Mumbai , 10  
Address  opd no 1 ,department streerog prasutishastra 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 shastra 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  
 
Details of Contact Person
Scientific Query
 
Name  Dr Seema Mehre  
Designation  Professor And HOD  
Affiliation  Y.M.T.Ayurvedic Medical College,And Hospital , P.G.Institute , Kharghar , Navi Mumbai , 10  
Address  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 , dept streerog prasuti shastra [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  9930940403  
Fax    
Email  seema.mehre@gmail.com   
 
Details of Contact Person
Public Query
 
Name  Dr Trupri Jaideep Kale  
Designation  PhD Scholar  
Affiliation  Y.M.T.Ayurvedic Medical College,And Hospital , P.G.Institute , Kharghar , Navi Mumbai , 10  
Address  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  
 
Primary Sponsor  
Name  Y.M.T.Ayurvedic Medical College,And Hospital , P.G.Institute , Kharghar , Navi Mumbai , 10  
Address  Dr G.D.Pol Foundation , Y.M.T.Ayurvedic Medical College,And Hospital , P.G.Institute , Kharghar , Navi Mumbai , 10  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Ashtang Ayurved Mahavidyala Pune   Ashtang Ayurved Mahavidyalaya Pune  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Trupti Jaideep Kale   Y.M.T.Ayurvedic Medical College,And Hospital , P.G.Institute , Kharghar , Navi Mumbai , 10   Dr G.D.Pol Foundation , Y.M.T.Ayurvedic Medical College,And Hospital , P.G.Institute , Kharghar , Navi Mumbai , 10
Mumbai (Suburban)
MAHARASHTRA 
8007211418

drtruptkale80@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Y.M.T.Ayurvedic Medical College,And Hospital , P.G.Institute , Kharghar , Navi Mumbai , 10  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium. Ayurveda Condition: GARBA-VYAPAT,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Gokshursiddha ghrit , Reference: Sushrut Sharirsthan 10, Route: Oral, Dosage Form: Ghrita, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 6 Weeks, anupAna/sahapAna: Yes(details: Koshnajal ), Additional Information: -
2Comparator Arm (Non Ayurveda)-L Arginine 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  
 
ExclusionCriteria 
Details  Medical & surgical illness complicating pregnancy such as anaemia, heart disease, TB, glycosuria, thyroid dysfunction, jaundice, STD, pyelo-nephritis, epilepsy, viral infection, asthma, hypertension disorders (Pre- eclampsia, eclampsia) , chronic renal disease, infections etc
Multiton pregnancies
 
 
Method of Generating Random Sequence   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 fetus  in 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 growth  of the fetus but  a mental and cognitive function is also affected.

Intrauterine growth restriction is a common public health problem. 10-15% pregnancies are affected  worldwide.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 is  4-8 times higher in  IUGR fetuses.

In garbhani her ahar rasa is devided into three parts  for

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 garbha  one has to do brihan chikitsa .

We can corelate vatabhipanna shushka garbh with  asymmetrical 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.

 Perinatal  mortality and morbidity is  mostly due to IUGR fetuses.

There is no any specific drug for IUGR other than l arginine.

Ayurveda stated many drugs for  garbh -garbhini brihin chikitsa .

Evidence based research is neded to apply these drugs to the population.

 
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