| 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
|
|
|
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
|
|
|
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 |
|
|
|
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 Dushti, Acharya 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. |