| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N979||Female infertility, unspecified. Ayurveda Condition: VANDHYA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | 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 | | 2 | Comparator Arm | Procedure | - | 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. |