| CTRI Number |
CTRI/2025/02/080959 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
diagnosis and treatment for polycystic ovarian diseases related infertility according to gene expression ultrasound and immunohistochemistry |
|
Scientific Title of Study
|
A diagnostic and Ayurvedic therapeutic approach for
endometrial receptivity in patients of polycystic ovarian syndrome based on
Radiological Uterine biophysical profile, Immunohistochemistry and Gene
expression. |
| 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 Anuradha Roy |
| Designation |
Associate Professor |
| Affiliation |
Banaras Hindu University, Varanasi |
| Address |
Department of Prasuti Tantra, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi,
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9956630433 |
| Fax |
|
| Email |
dranuradha369@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anuradha Roy |
| Designation |
Associate Professor |
| Affiliation |
Banaras Hindu University, Varanasi |
| Address |
Department of Prasuti Tantra, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi,
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9956630433 |
| Fax |
|
| Email |
dranuradha369@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anuradha Roy |
| Designation |
Associate Professor |
| Affiliation |
Banaras Hindu University, Varanasi |
| Address |
Department of Prasuti Tantra, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi,
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9956630433 |
| Fax |
|
| Email |
dranuradha369@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Eminence, Banaras Hindu University, Varanasi, India,221005 |
|
|
Primary Sponsor
|
| Name |
Institute of EminenceIOE |
| Address |
Banaras Hindu University, Varanasi, India, 221005 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anuradha Roy |
Institute of Medical Sciences, Banaras Hindu University |
Department of Prasuti Tantra, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi, 221005
Varanasi
UTTAR PRADESH |
09956630433
dranuradha369@gmail.com |
| Dr Anuradha Roy |
Sir Sundarlal Hospital, IMS, BHU |
Department of Prasuti Tantra, Faculty of Ayurveda, Institute of Medical Sciences, BHU, Varanasi 05, UP, India
Varanasi
UTTAR PRADESH |
9956630433
-
dranuradha369@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, Banaras Hindu University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N970||Female infertility associated withanovulation. Ayurveda Condition: ARTAVAVAHA-SROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | uttara-bastiH, उत्तर-बस्तिः | (Procedure Reference: Charak Samhita, Procedure details: after stoppage of menses for 5 days daily once uttarabasti will be done for 3 cycles)
(1) Medicine Name: Shatpushpa oil, Reference: Kashyap Samhita, Route: Vaginal, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 5 Days | | 2 | Comparator Arm | Procedure | - | endometrial biopsy | (Procedure Reference: DC dutta, Procedure details: endometrial biopsy will be taken during 21 to 24 day of cycle & send for gene expression & immunohistochemistry)
|
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Diagnosed cases of PCOS yearning conception.
Patient giving consent for uttarabasti procedure and investigations
And willing for follow ups. |
|
| ExclusionCriteria |
| Details |
<21 years and >40 years of age patient.
Unmarried PCOS patients
Patients with huge myoma and adenomyosis.
Extensive cervical erosion and vaginal infection.
HIV, HBsAg, HCV positive Patients. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| diagnostic alteration in endometrial receptivity |
baseline, after 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| endometrial receptivity improvements |
baseline, after 4weeks, after 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
02/03/2025 |
| 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="0"
Months="6"
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
|
Gap in knowledge :As many previous published researches showed that uttarabasti has role in improving the chances of conception and enhanced fertility but no work has been done to show effect of uttarabasti on markers of endometrial receptivity in specific. Novelty :The present study framed mainly for disorders of endometrial receptivity in patients with PCOS, where we planned to see the differences in the indicators of endometrial receptivity including Applebaum’s score via sonography, alphavbeta3integrin via immunihistochemical study and 7 genes expression (related to endometrial receptivity as per previous published research work) between PCOS diagnosed female patients with fertile females having live births as control group Objectives :Assessment of Applebaum’s score, AlphaVBeta3 integrin expression and expression of 7 genes related to endometrial receptivity (HOXA10, HOXA11, LIF, AR, Mucin1, PGR, alphavbeta3) during implantation window in patients of PCOS. Methods :Itwill be an open label controlled clinical trial and the setting site will be the BHU,Varanasi. Expected outcome :Uttarabasti can improve endometrial receptivity by increasing, Applebaum’s score, alphavbeta3 integrin expression and by up regulating gene expression during implantation window in patients of PCOS. |