FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/08/072161 [Registered on: 08/08/2024] Trial Registered Prospectively
Last Modified On: 06/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Assessment of Ashta Artava Dushti (menstrual abnormalities) and its prevalence in infertility. 
Scientific Title of Study   A cross sectional survey study to assess ashta artava dushti and its prevalence in 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 Kulkarni Shraddha Vinayak 
Designation  P G Scholar 
Affiliation  sri sri college of ayurvedic science and research hospital, bangalore 
Address  OPD No.10, Department Of Prasuti Tantra And Stree Roga,Sri Sri College of Ayurvedic Science and Research, Udayapura P.O.,21 KM, Kanakapura Rd, Bangalore, Karnataka 560082 India

Bangalore Rural
KARNATAKA
560082
India 
Phone  08050436049  
Fax    
Email  drshraddhavk21@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shruti S Patil 
Designation  Associate Professor, Department of Prasuti Tantra And Streeroga 
Affiliation  sri sri college of ayurvedic science and research hospital, bangalore 
Address  OPD No.10, Department Of Prasuti Tantra And Stree Roga,Sri Sri College of Ayurvedic Science and Research, Udayapura P.O.,21 KM, Kanakapura Rd, Bangalore, Karnataka 560082 India

Bangalore Rural
KARNATAKA
560082
India 
Phone  9886269111  
Fax    
Email  shrutivinsun@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kulkarni Shraddha Vinayak 
Designation  P G Scholar 
Affiliation  sri sri college of ayurvedic science and research hospital, bangalore 
Address  OPD No.10, Department Of Prasuti Tantra And Stree Roga,Sri Sri College of Ayurvedic Science and Research, Udayapura P.O.,21 KM, Kanakapura Rd, Bangalore, Karnataka 560082 India

Bangalore Rural
KARNATAKA
560082
India 
Phone  8050436049  
Fax    
Email  drshraddhavk21@gmail.com  
 
Source of Monetary or Material Support  
Sri Sri College of Ayurvedic Science and Research Hospital,Survey No.269/270, B.M. Kaval, Udayapura P.O., 21 KM, Kanakapura Rd, Bengalore, Karnataka 560082 
 
Primary Sponsor  
Name  Not applicable 
Address 
Type of Sponsor  Other [Not applicable] 
 
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 Kulkarni Shraddha Vinayak  Sri Sri College of Ayurvedic Science and Research  OPD No. 10, Department Of Prasuti Tantra And Stree Roga,Sri Sri College of Ayurvedic Science and Research, B.M. Kaval, UdayapuraP.O., Kanakapura Road, Bangalore, Karnataka
Bangalore Rural
KARNATAKA 
8050436049

drshraddhavk21@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Sri Instuitional Ethical Committee  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
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Subjects having regular, irregular menstrual cycles.
Subjects having Primary and secondary infertility. (Anxious to conceive with unprotected sex since 6 months for more than 35 years of age and 1 year for less than 35 years of age.)
 
 
ExclusionCriteria 
Details  Subjects below the age of 20 years.
Subjects above the age of 45 years.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assessment of Artava dushti in infertility   0th day 
 
Secondary Outcome  
Outcome  TimePoints 
Artava dushti is prevalent in infertility.  0th day 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   25/08/2024 
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="2"
Days="15" 
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  

Ovarian hormones (Beeja), menstrual blood (Rajas), and menstrual ovum are all referred to as Artava  (Upadhatu).

Artava is necessary for both, the embryo’s growth and the health of female reproduction as a whole.

According to Ayurveda, the majority of menstrual disorders fall under the category of "Ashtartava  Dushti ". This is also known as Rutuvyapad and Artava vyapad. They are eight in number including Vataja, Pittaja, Kaphaja, Kunapagandhi, Granthibhuta, Putipuya, Ksheena, Mutrapurishagandha.

One of the etiological factors listed in Yonivyapad Nidana is Pradushta Artava.

While describing Ashta Artava DushtiAcharya Sushruta in Sharira sthana mentioned that person affected with Artava Dushti is incapable of begetting children.

Therefore, as treatment depends on the type of Artava Dushti, it is crucial to get a correct diagnosis. A woman’s power to procreate is what makes her important.

The term "Vandhyatwa" is used to describe the delay or obstruction of this capacity.

Infertility is defined as the inability of a couple to achieve conception after 1 year of unprotected coitus.

In India, the overall prevalence of primary infertility lies in between 3.9% and 16.8%, as per WHO estimates. Infertility is significant clinical problem today, affecting 8-12% of couples worldwide.

It can be difficult to evaluate the typical Artava Dushti symptoms, which makes a diagnosis difficult and makes selecting the right treatment challenging.

Since very less research has been done on Artava Dushti, an attempt has been made to analyze the classical Ayurvedic symptoms of Ashta Artava Dushti.

Few reasons of infertility are understood, thus it’s crucial to make the right diagnosis and treat them from the source according to Ayurveda’s Shuddha Artava

The purpose of this study is to better understand and identify the cause.

 

 
Close