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CTRI Number  CTRI/2020/02/023448 [Registered on: 19/02/2020] Trial Registered Prospectively
Last Modified On: 31/01/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to evaluate the effect of Shatavari ghrita on fetal outcome w.s.r. to birth weight 
Scientific Title of Study   An open label randomized controlled clinical trial to evaluate the effect of Shatavari ghrita during pregnancy on fetal outcome w.s.r. to birth weight 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nidhi Tahlan 
Designation  PG Scholar in Prasuti Tantra evam Stri Roga  
Affiliation  All India Institute Of Ayurveda 
Address  All India Institute Of Ayurveda Gautampuri Sarita Vihar Mathura Road New Delhi

South
DELHI
110076
India 
Phone  9953051714  
Fax    
Email  tahlan.nidhi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Sujata Kadam 
Designation  MS(ayurveda) PhD in Prasuti Tantra evam Stri Roga 
Affiliation  All India Institute Of Ayurveda 
Address  All India Institute Of Ayurveda Gautampuri Sarita Vihar Mathura Road New Delhi

South
DELHI
110076
India 
Phone  9890305370  
Fax    
Email  sujatadkadam@gmail.com  
 
Details of Contact Person
Public Query  
Name  Nidhi Tahlan 
Designation  PG Scholar in Prasuti Tantra evam Stri Roga  
Affiliation  All India Institute Of Ayurveda 
Address  All India Institute Of Ayurveda Gautampuri Sarita Vihar Mathura Road New Delhi

South
DELHI
110076
India 
Phone  9953051714  
Fax    
Email  tahlan.nidhi@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Ayurveda 
 
Primary Sponsor  
Name  All India Institute Of Ayurveda 
Address  All India Institute Of Ayurveda Gautampuri Sarita Vihar Mathura Road New Delhi 
Type of Sponsor  Research institution and hospital 
 
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 
Nidhi Tahlan  All India Institute Of Ayurveda  Room no 202,second floor,hospital block, Prasuti Tantra evam Stri Roga Department, Gautampuri, Sarita Vihar,Mathura Road, New Delhi 110076
South
DELHI 		 9953051714

tahlan.nidhi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  primi and second gravida with gestational age 12-14 weeks onwards to 34 weeks 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Routine antenatal care  Iron capsule (ferrous ascorbate 100 mg,folic acid 1.5 mg)OD for 6 months (12 weeks onwards till delivery); calcium tablet(calcium carbonate and vit. D3) 500 mg OD for 6 months (12 weeks onwards till delivery)  
Intervention  Shatavari Ghrita along with routine antenatal care  Shatavari Ghrita 10 ml BD for 5 months(12-14 weeks onwards to 34 weeks);Iron capsule (ferrous ascorbate 100 mg,folic acid 1.5 mg)OD for 6 months (12 weeks onwards till delivery); calcium tablet(calcium carbonate and vit. D3) 500 mg OD for 6 months (12 weeks onwards till delivery)  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Primi and second gravida with gestational age 12 to 14 weeks;able and willing to participate and provide signed informed consent 
 
ExclusionCriteria 
Details  Severe anaemia Hb <7 gm/dl; pregnancy complicated by placenta praevia, coexisting fibroid, any malignancy,twins; pregnancy complicated with diseases such as hypo or hyperthyroidism, cardiovascular diseases, diabetes.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Evaluate the effect of oral administration of Shatavari ghrita during pregnancy on fetal outcome w.s.r. to birth weight  Baby fetal weight by USG; Birth weight will be noted at the time of delivery and on 10th after delivery; APGAR score 
 
Secondary Outcome  
Outcome  TimePoints 
Evaluate the effect of oral administration of Shatavari ghrita in garbhini i.e. to minimize the complications of pregnancy  Every 15th day in 4th to 6th month;every 8th day in 7th to 9th month; Gestational age at the time of labour; Mode of delivery; Duration of labour 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 
Date of First Enrollment (India)   19/03/2020 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This is an open label randomized controlled clinical trial to evaluate the effect of oral administration of Shatavari ghrita in a dose of 10 ml twice daily in pregnant women from 12 weeks onwards to 34 weeks on fetal outcome w.s.r. to birth weight.In one group shatavari ghrita will be given alongwith routine antenatal care and the other group will be given only the routine antenatal care. The study will be conducted in All India Institute Of Ayurveda, New Delhi, India. The primary outcome measure will be to evaluate the effect of Shatavari ghrita on fetal outcome w.s.r. to birth weight. Birth weight will be noted at the time of delivery and on 10th day after delivery. The secondary outcome measure will be to evaluate the effect of Shatavari ghrita in garbhini i.e. to minimize the complications of pregnancy. Follow up will be on every 15th day in 4th to 6th month and every 8th day in 7th to 9th month.Gestational age at the time of labour, mode of delivery and duration of labour will also be noted down. 
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