| CTRI Number |
CTRI/2025/08/093076 [Registered on: 14/08/2025] Trial Registered Prospectively |
| Last Modified On: |
14/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Validation of Nadi Tarangini Device ( Nadi Pariksha) for identifying the PCOS among the women in India - Cross Sectional Study |
|
Scientific Title of Study
|
Validation of Nadi Tarangini for identifying the PCOS among the women in India - Cross Sectional Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pradnya Shirke |
| Designation |
Professor |
| Affiliation |
Opd NO. 2 Stree Roga Evum Prasuti Tantra Department Dr D Y Patil College of Ayurved And Research Centre Pimpri Pune Maharashtra |
| Address |
OPD NO. 2 Stree Roga Evum Prasuti Department Tantra Dr D Y Patil college of Ayurved and Research Centre Pimpri Pune Maharashtra
Pune
MAHARASHTRA
411018
India |
| Phone |
9623446110 |
| Fax |
|
| Email |
pradnyashirke2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pradnya Shirke |
| Designation |
Professor |
| Affiliation |
OPD No. 2 Stree Roga Evum Prasuti Tantra Department Dr D Y Patil College of Ayurved And Research Centre Pimpri Pune Maharashtra |
| Address |
OPD NO. 2 Stree Roga Evum Prasuti Tantra Department Dr D Y Patil college of Ayurved and Research Centre Pimpri Pune Maharashtra
Pune
MAHARASHTRA
411018
India |
| Phone |
9623446110 |
| Fax |
|
| Email |
pradnyashirke2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pradnya Shirke |
| Designation |
Professor |
| Affiliation |
OPD No. 2 Stree Roga Evum Prasuti Tantra Department Dr D Y Patil College of Ayurved And Research Centre Pimpri Pune Maharashtra |
| Address |
OPD No. 2 Stree Roga Evum Prasuti Tantra Department Dr D Y Patil college of Ayurved and Research Centre Pimpri Pune Maharashtra
Pune
MAHARASHTRA
411018
India |
| Phone |
9623446110 |
| Fax |
|
| Email |
pradnyashirke2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil College of Ayurved and Research Centre Pimpri Pune Maharashtra |
|
|
Primary Sponsor
|
| Name |
Dr Aniruddha Joshi |
| Address |
Dr D Y Patil College of Ayurved and Research Centre Pimpri Pune Maharashtra |
| Type of Sponsor |
Other [Self ] |
|
|
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 Pradnya Shirke |
Dr D Y Patil College of Ayurved and Research Centre |
OPD No. 2 Stree Roga Evum Prasuti Tantra Department
Pune
MAHARASHTRA |
9623446110
pradnyashirke2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR. DYPCA AND RC INSTITUTIONAL ETHICS COMMITTEE PIMPRI PUNE 411018 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E889||Metabolic disorder, unspecified. Ayurveda Condition: ARTAVAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Known female patients of PCOS having oligomenorrhea cycles more than 35days apart or less than 8 menses a year and ultrasound report showing polycystic pattern of ovary |
|
| ExclusionCriteria |
| Details |
Hospitalized patients with life supports Patients on corticosteroid and oral Contraceptive medications
Those who are not willing to undergo the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Establishment of AI driven correlations between nadi patterns and PCOS cases |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify nadi graph patterns related to PCOS and correlate the same with Ashtavidh Parikshan clinical examination with Questionnaire in Known PCOS subjects |
3 months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
25/08/2025 |
| 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="3"
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
|
This study will be a case control study conducted in known PCOS subjects aged between 18 to 40 years in urban and rural areas of Pune having Oligomenorrhea and ultrasound report showing Polycystic pattern of ovary. This study will identify the Nadi graph patterns related to PCOS and correlate the same with Ashtavidh Parikshan clinical examination with Questionnarie measures. |