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CTRI Number  CTRI/2024/12/078765 [Registered on: 30/12/2024] Trial Registered Prospectively
Last Modified On: 30/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   An observational study to survey the prevalence rate of rachnatmak vikriti(anatomical abnormalities) of kshetra(female reproductive organ) causing stri vandhyatva(infertility) 
Scientific Title of Study   A CROSS-SECTIONAL SURVEY STUDY TO OBSERVE THE PREVALENCE OF VARIOUS RACANATMAKA VIKRTI (ANATOMICAL ABNORMALITIES) OF KSÌ£ETRA (FEMALE REPRODUCTIVE ORGANS) CAUSING STRI VANDHYATVA (INFERTILITY) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Riddhi Ashokbhai Amreliya 
Designation  PG Scholar 
Affiliation  J. S. Ayurveda Mahavidyalaya 
Address  Post Graduate Department of Rachana Sharira, J.S. Ayurveda Mahavidyalaya, College Road, Nadiad, Kheda, Gujrat
Post Graduate Department of Rachana Sharira, J.S. Ayurveda Mahavidyalaya, College Road, Nadiad, Kheda, Gujrat
Kheda
GUJARAT
387001
India 
Phone  9408451862  
Fax    
Email  riddhi.amreliya98@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Seetharama Mithanthaya 
Designation  Professor 
Affiliation  J.S. Ayurveda Mahavidyalaya 
Address  Post Graduate Department of Rachana Sharira, J.S. Ayurveda Mahavidyalaya, College Road, Nadiad, Kheda, Gujrat
Post Graduate Department of Rachana Sharira, J.S. Ayurveda Mahavidyalaya, College Road, Nadiad, Kheda, Gujrat
Kheda
GUJARAT
387001
India 
Phone  9901732256  
Fax    
Email  drsitharam1@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Seetharama Mithanthaya 
Designation  Professor 
Affiliation  J.S. Ayurveda Mahavidyalaya 
Address  Post Graduate Department of Rachana Sharira, J.S. Ayurveda Mahavidyalaya, College Road, Nadiad, Kheda, Gujrat
Post Graduate Department of Rachana Sharira, J.S. Ayurveda Mahavidyalaya, College Road, Nadiad, Kheda, Gujrat
Kheda
GUJARAT
387001
India 
Phone  9901732256  
Fax    
Email  drsitharam1@gmail.com  
 
Source of Monetary or Material Support  
J S ayurved Mahavidyalaya and P D Patel Ayurveda Hospital,collage road Nadiad dis Kheda India-387001 
 
Primary Sponsor  
Name  J S Ayurveda Mahavidyalaya  
Address  collage road Nadiad, District-Kheda, Gujrat-387001 
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 
DrRiddhi Amreliya  P D Patel Ayurvedic hospital  Post Graduate Department of Rachana Sharira, P D Patel Ayurvedic Hospital with J S Ayurveda Mahavidyalaya, College Road, Nadiad, Kheda, Gujrat
Kheda
GUJARAT 		 9408451862

riddhi.amreliya98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee MAM University-Nadiad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N739||Female pelvic inflammatory disease, unspecified. Ayurveda Condition: VANDHYA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Patients between 20 to 40 years of age.
Women with primary and secondary infertility due to diagnosed anatomical abnormalities in their reproductive organs.
Congenital and acquired anomalies related to Female genital organs. (Uterine, tubal, ovarian, cervical, vaginal factors). 
 
ExclusionCriteria 
Details  Patients below 20 and above 40 years of age.
Infertility due to non-anatomical factors: anovulation, uterine dysfunction, cervical cellulitis, vaginitis, and any other systemic illness.
Infertility associated with hormonal imbalance: hypothalamic, thyroid disorders, etc. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
with the help of USG - pelvis & adnexa report, The study will derive the prevalence of Racanatmaka vikrÌ£ti of ksÌ£etra causing Stri Vandhyatva which may simplify the complexity of the diagnosis of StriÌ„ Vandyatva.  The observation will be completed within 1 year and 6 months of the duration. 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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   N/A 
Date of First Enrollment (India)   15/01/2025 
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   Infertility is the failure to conceive (regardless of cause) after 1 year of unprotected intercourse. Since the Vedic period, Racanatmaka vikrÌ£ti of ksÌ£etra resulting in Vandhyatva (Infertility) has been acknowledged. The first systemic literature of health science Ayurveda has given detailed descriptions in a classified manner. Four important factors as Garbha samÌ£bhava saÌ„magriÌ„ that is rÌ£tu, ksÌ£etra, ambu, and biÌ„ja have been explicated by Ä€caÌ„ryas. These factors are essential for conception. Any irregularity in the Garbha samÌ£bhava saÌ„magriÌ„ can lead to infertility. KsÌ£etra is stated as an important GarbhotpaÌ„daka bhaÌ„va and regarded as one of the most important factors for conception. Different aÌ„caÌ„ryas have different considerations for ksÌ£etra. Some Ä€yurveda scholars considered KsÌ£etra as only garbhaÌ„Å›aya or the whole female body or the female reproductive tract. In this context, we refer to the entire female reproductive system as KsÌ£etra, which includes dÌ£imbagranthi (ovaries), dÌ£imbanalikaÌ„ (fallopian tubes), garbhaÌ„Å›aya (uterus), garbhaÌ„Å›aya bandhana (ligaments of uterus), yoni (vagina).   In any community, infertility affects approximately 5-15% of reproductive-aged couples. Over the past 50 years, its general frequency has been consistent, although the etiology and patient age have changed. There is a corresponding rise in the incidence of infertility as women age. The female is directly responsible in about 40 -55 % of cases. Hence, there is need to observe the prevalence of the congenital and other anatomical abnormalities (racanaÌ„tmaka vikrÌ£ti) that are responsible for Vandhyatva by understanding the anatomy of pelvic viscera and the prevalence of various anatomical abnormalities causing female infertility will enable medical professionals to assess patients and treat them appropriately for an effective outcome. The study aims to observe the prevalence of RacanaÌ„tmaka vikrÌ£ti of KsÌ£etra (female reproductive organs) in the development of  StriÌ„ vandhyatva. The Objectives of the Study are to do a literary study on the anatomy of female reproductive organs, a literary study of StriÌ„ vandhyatva, and a survey to observe the prevalence of RacanaÌ„tmaka vikrÌ£ti of KsÌ£etra (female reproductive organs) causing StriÌ„ vandhyatva. 
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