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CTRI Number  CTRI/2024/10/075848 [Registered on: 24/10/2024] Trial Registered Prospectively
Last Modified On: 18/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Clinical study to see the effect of yashtimadhu gambhari siddha ksheerpaan and L-arginine in 64 pregnant women having asymmetrical Intra uterine growth restriction of babies. 
Scientific Title of Study   A Comparative Clinical Study of Yashtimadhu, Gambhari Siddha Ksheerpaan And L- Arginine in Garbhashosha With Special Reference to Asymmetrical IUGR 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anushri Ashok Dhok 
Designation  Post graduate resident  
Affiliation  APMS Ayurveda Mahavidyalaya Sion Mumbai 
Address  Department of Prasutitantra & Strirog 3rd floor APMs Ayurved Mahavidyalaya near sion railway station Sion East Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  7020844954  
Fax    
Email  anushreedhok4@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sujata Shrikant Jagtap 
Designation  Associate Professor and HOD 
Affiliation  APMS Ayurveda Mahavidyalaya Sion Mumbai 
Address  Department of Prsutitantra & Strirog APMs Ayurved Mahavidyalaya near sion railway station Sion East Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  9820556568  
Fax    
Email  sujatashrikantjagtap@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sujata Shrikant Jagtap 
Designation  Associate Professor and HOD 
Affiliation  APMS Ayurveda Mahavidyalaya Sion Mumbai 
Address  Department of Prasutitantra & Strirog APMs Ayurved Mahavidyalaya near sion railway station Sion East Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  9820556568  
Fax    
Email  sujatashrikantjagtap@gmail.com  
 
Source of Monetary or Material Support  
APMs Ayurved Mahavidyalaya Near Sion Station Sion East Mumbai 400022 Maharashtra India 
 
Primary Sponsor  
Name  Anushri Ashok Dhok 
Address  APMs Ayurved Mahavidyalaya sion near sion railway station sion Mumbai 400022 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anushri Ashok Dhok  APMs Seth R V Ayurvedic Hospital  OPD no 8 APMs Ayurved Mahavidyalaya and Seth R V Ayurved Hospital near sion railway station Sion East Mumbai 400022
Mumbai
MAHARASHTRA 		 7020844954

anushreedhok4@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
APMs Ayurved Mahavidyalaya Sion IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:P050||Newborn light for gestational age. Ayurveda Condition: GARBA-VYAPAT,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: yashtimadhu gambhari ksheerpaka, Reference: BHAISHJYA RATNAWALI 68/49, Route: Oral, Dosage Form: Ksheerpaka, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: -
2Comparator Arm (Non Ayurveda)-L- arginine sachet route - oral , dosage form -1/2 sachet in 1 glass of water frequency - BD Duration - 1 month .
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  38.00 Year(s)
Gender  Female 
Details  female patient age group from 20-38 Yrs ,Married patient .
1. Pregnancy with gestational Age between 28 - 36 wks both primiand multigravida
2. IUGR associated with Oligohydramnios , mild anemia and mild PIH Associated
3. USG :- S/O IUGR
4. Voluntary willing patients.
5.Patients irrespective of a) religion
b)cast
c)Socio economic status
d)Occupation 
 
ExclusionCriteria 
Details  Associated fetal anomalies.
1. Pregancy complicated with multiple gestation
2. Placental Abnormality.
3. Patient having major respiration cardiovascular and abdominal
pathology.
4.Patient having sever oligohydramnios, sever PIH & severe anemia 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
USG Findings
Uniform increase in abdomen size and weight gain of mother
NST 		 1 Month 
 
Secondary Outcome  
Outcome  TimePoints 
1.Well Distinguished fetal movements (At least 3 times/hr)
2.Symphysis fundal height
3. Abdominal circumference
4.maternal weight gain
5. In USG findings -
fetal weight gain
HC and AC ratio
AFI
 		 1 MONTH 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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 4 
Date of First Enrollment (India)   01/11/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   Maternal nutrition during pregnancy period has profound effect on the development of fetus.


The improper nutrition during pregnancy may otherwise result in abortion, IUGR or other fetal abnormalities. proper weight gain is a symbol of healthy pregnancy which directly effects neonatal birth weight.


A fetus is growth Restricted if it’s gestational age less than 10th percentile for gestational age. The growth restriction in utero is evaluated with the Anunnata Kukshi (fundal height less than 10th percentile) and Garbha Aspandana (reduced fetal activity mainly due to reduced amniotic fluid ) which are the Feature of Grabhakshay IUGR for its mangrement. 


Acharya has mentioned the used of ksheer paan ( medicated milk) in 7th month onwards to nourish the growth restricted fetus. In ksheer paan Aacharya has mentioned that yashtimadhu and gambhari siddha ksheer with Seeta as Ingredients of Ksheer paan. Due to bruhaniya,balya and garbhaposhak , jeevaniya action of these drug formulation Can be used in management of Gobhashosha.


Yashtimadhu and Gambhari siddha ksheer with seeta  contents mainly belongs to Madhur Sakanda Gana . Garbhashosha occurs due to Rasakshaya take place which leads to vitiation of vata and it’s ultimately leads to Dhatukshaya in garbhini & garbha relieved by Yashtimadhu & Gambhari siddha ksheerpaan by it’s Balya and Bruhaniya properties. so keeping all above things in mind ksheer paan Selected to evaluate and establish safe , cost effective Ayurvedic remedy on GarbhaShosha (Asymmetrical IUGR).
 
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