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CTRI Number  CTRI/2025/09/095398 [Registered on: 24/09/2025] Trial Registered Prospectively
Last Modified On: 11/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative Study of Phala Ghrita and Brihat Shatavari Ghrita Uttarabasti on Endometrial Receptivity in Unexplained Infertility 
Scientific Title of Study
Modification(s)  
A Randomized Clinical Trial to Compare the Efficacy of Phala Ghrita Uttarabasti and Brihat Shatavari Ghrita Uttarabasti on Endometrial receptivity in Unexplained Infertility 
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 Shweta Raturi 
Designation  PhD Scholar 
Affiliation  National Institute of Ayurveda 
Address  OPD no 26 and 27 Department of Prasuti Tantra and Stree Roga National Institute of Ayurveda Jorawar Singh Gate Amer Road Jaipur Rajasthan
OPD no 26 and 27 Department of Prasuti Tantra and Stree Roga Jorawar Singh Gate Amr Road Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India 
Phone  9811929679  
Fax    
Email  raturi.shweta02@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr K Bharathi 
Designation  Professor Head of the Department  
Affiliation  National Institute of Ayurveda 
Address  Department of Prasuti Tantra Stree Roga National Institute of Ayurveda Jorawar Singh Gate Amer Road Jaipur Rajasthan
Jorawar Singh Gate Amr Road Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India 
Phone  9799997940  
Fax    
Email  baruhunt@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shweta Raturi 
Designation  PhD Scholar 
Affiliation  National Institute of Ayurveda 
Address  OPD No 26 and 27 Department of Prasuti Tantra and Stree Roga National Institute of Ayurveda Jorawar Singh Gate Amer Road Jaipur Rajasthan
OPD No 26 and 27 Department of Prasuti Tantra and Stree Roga Jorawar Singh Gate Amr Road Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India 
Phone  9811929679  
Fax    
Email  raturi.shweta02@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda 
 
Primary Sponsor  
Name  National Institute of Ayurveda 
Address  Jorawar Singh Gate Amer Road Jaipur Rajasthan 
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 
Dr Shweta Raturi  National Institute of Ayurveda  OPD number 26 27 Department of Prasuti Tantra and Stree Roga
Jaipur
RAJASTHAN 
9811929679

raturi.shweta02@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee National Institute of Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N979||Female infertility, unspecified. Ayurveda Condition: VANDHYA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-uttara-bastiH, उत्तर-बस्तिः (Procedure Reference: Charak Siddhi Sthana 9, Procedure details: For 6 days after cessation of menses for 3 Cycles)
(1) Medicine Name: Phala Ghrita, Reference: Ashtang Hridaya Uttaratantra – 34/63-67 , Route: Vaginal, Dosage Form: Ghrita, Dose: 7(ml), Frequency: od, Duration: 6 Days
2Comparator ArmProcedure-uttara-bastiH, उत्तर-बस्तिः (Procedure Reference: Charak Siddhi Sthana 9, Procedure details: For 6 days after cessation of menses for 3 Cycles)
(1) Medicine Name: Brihat Shatavari Ghrita, Reference: Charak Chikitsa 30, Route: Vaginal, Dosage Form: Ghrita, Dose: 7(ml), Frequency: od, Duration: 6 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Married female patients between age group 20 years to 40 years.
Patients diagnosed as a case of unexplained infertility with B/l patent fallopian tubes, positive ovulatory status, and normal uterine cavity.
Normal semen analysis of partner
 
 
ExclusionCriteria 
Details  Women with known cause of infertility.
Known case of uro-genital infections, reproductive tract disorders, sexually transmitted diseases and anatomical defect of reproductive/urogenital tract.
Known case of medical co morbidity (diabetes mellitus, hypothyroidism) .
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Changes in receptivity and expression of alpha v beta 3 integrin in endometrium  3 menstrual cycle 
 
Secondary Outcome  
Outcome  TimePoints 
safety profile of drugs and Uttarabasti procedure   3 menstrual cycle 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   15/10/2025 
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  

1.   Infertility affects a significant number of couples worldwide, and for about 10-30% of them, the reason remains unknown – a condition called unexplained infertility . One of the key issues in infertility, including unexplained infertility, can be problems with the endometrium, which is the lining of the uterus. For a pregnancy to occur, an embryo needs to successfully attach to a healthy and receptive endometrium. One important factor for this attachment is a protein called alpha V beta 3 integrin, which is found in the uterine lining. Studies have shown that women who have trouble with implantation often have lower levels of this protein. Ayurveda offers various treatments for infertility, and one such method is Uttarabasti. This involves administering medicated oils or ghee directly into the uterus. This study aims to investigate two specific Ayurvedic preparations, Phala Ghrita and Brihat Shatavari Ghrita, administered via Uttarabasti. These preparations have been used in Ayurveda to improve fertility and reproductive health. Currently, there’s limited scientific evidence to explain how these Ayurveda treatments work at a molecular level. This research seeks to bridge that gap by scientifically comparing the effects of Phala Ghrita Uttarabasti and Brihat Shatavari Ghrita Uttarabasti on improving endometrial receptivity and, specifically, the expression of alpha V beta 3 integrin in women with unexplained infertility. The study will involve 80 women (40 in each group) aged 20-40 with unexplained infertility. They will receive either Phala Ghrita or Brihat Shatavari Ghrita via Uttarabasti for six days after their period, for three cycles. Researchers will assess changes in their endometrial receptivity using a scoring system and measure the expression of alpha V beta 3 integrin in their endometrial tissue before and after the treatment. The study will also monitor for any potential side effects. The goal is to see if these Ayurvedic interventions can improve the endometrial receptivity, specifically by enhancing the expression of alpha V beta 3 integrin, and ultimately increase the chances of successful embryo implantation for women with unexplained infertility. If successful, this study could offer a new, holistic treatment option, combining traditional wisdom with modern scientific understanding to help couples struggling to conceive. The study will be conducted over 30 months and will only begin after receiving ethical approval and registration.

 
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