| CTRI Number |
CTRI/2025/04/084472 [Registered on: 09/04/2025] Trial Registered Prospectively |
| Last Modified On: |
21/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Role of screening method to assess changes in menstrual diseases |
|
Scientific Title of Study
|
Palmer Dermatoglyphics for screening Aartav
Vaha Srotovikar with special reference to
Polycystic Ovarian Syndrome - A 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 |
Dr Smitaraje Wader |
| Designation |
Professor |
| Affiliation |
KAHER shri BMK Ayurved Mahavidyalaya Shahapur Belagavi |
| Address |
Room number 23
Department of Prasuti tantra and Stree roga
KAHER Shri BMK Ayurved Mahavidyalaya and Hospital Shahapur Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9449946896 |
| Fax |
|
| Email |
sdwader2020@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep Shindhe |
| Designation |
Professor |
| Affiliation |
KAHER shri BMK Ayurved Mahavidyalaya Shahapur Belagavi |
| Address |
Department of Shalyatantra
KAHER shri BMK Ayurved Mahavidyalaya and Hospital Shahapur Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9986331357 |
| Fax |
|
| Email |
pshindhe@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Shindhe |
| Designation |
Professor |
| Affiliation |
KAHER shri BMK Ayurved Mahavidyalaya Shahapur Belagavi |
| Address |
Department of Shalyatantra
KAHER shri BMK Ayurved Mahavidyalaya and Hospital Shahapur Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9986331357 |
| Fax |
|
| Email |
pshindhe@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHER Shri B M K Ayurveda Mahavidyalaya and Hospital Belagavi |
|
|
Primary Sponsor
|
| Name |
Dr Smitaraje D Wader |
| Address |
Professor
Department of Rachana Sharir
KAHERs Shri BMK Ayurved Mahavidyalaya Shahapur Belagavi |
| Type of Sponsor |
Other [PhD Scholar] |
|
|
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 Smitaraje D Wader |
KAHERs Shri B M K Ayurveda Hospital Shahapur |
Room number 23
Department of Prasutitantra and Streeroga
Belgaum
KARNATAKA |
9449946896
sdwader2020@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KAHER Ethics Committee on Human Subjects for PhD Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N832||Other and unspecified ovarian cysts. Ayurveda Condition: ARTAVAVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
Diagnosed patients of Polycystic Ovarian Syndrome with symptoms of Anartava Nashtartava Aartavakshaya Aniyamit Aartava Aartavativrudhi Vandhyatva
Healthy females age matched and those who do not have symptoms of Polycystic Ovarian Syndrome |
|
| ExclusionCriteria |
| Details |
Female patients with history of Congenital deformity related to Uterus Ovary Fallopian tubes Cervix Vagina
History of Hysterectomy
History of Cancer
Skin diseases of hand
Deformity of hands amputed hands and amputed fingers
Injuries and scars of hands
Females of Polycystic Ovarian Syndrome with genetic disorder
Obese females with Polycystic Ovarian Syndrome |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fingertip pattern frequency |
At Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a Main line formula
b Main line index
c Three angles
d Interdigital ridge count
e Total finger ridge count
f Absolute finger ridge count
g Three Index |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="208"
Sample Size from India="208"
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)
|
01/05/2025 |
| 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="2"
Months="0"
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
|
Introduction - In Kashyap samhita he explained different lines and shapes like Swastika, Kamal, Shankh, Chakra and other auspicious signs on hands & soles.In ancient India Samudra shastra defined study of ridges classified ad Chakra, Shankh,& Padma,Same is explained in contemporary madicine in Dermatoglyphics as Whorl, Loop, Arch.In current scenario the most seen disease in females of reproductive age is Polycystic Ovarian Syndrome,In PCOS amenorhea,oligomenorhea,Dysfunctional uterine bleeding,Infertility are some of the symptoms seen. While in Ayurveda in Aartavavaha Srotovikar we found Anartava or Nashtartava, Aartavkshaya, aartavativrudhi, Vandhytava etc.So Dermatoglyphics can be utilised as it is simple, less time consuming for screening of Aartavavaha Srotovikar. Method - Palmer & finger prints of Patients of PCOS females and healthy Females are compared. Assessment - Qualitative & Quantitative parameters are used fo assessment. |