| CTRI Number |
CTRI/2026/03/105997 [Registered on: 12/03/2026] Trial Registered Prospectively |
| Last Modified On: |
11/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A CROSS SECTIONAL OBSERVATIONAL STUDY OF ENDOMETRIOSIS DIAGNOSIS USING THREE FOLD AYURVEDA DIAGNOSTIC METHOD |
|
Scientific Title of Study
|
ENDOMETRIOSIS IN RELATION TO AYURVEDA DIAGNOSTIC PRINCIPLES OF TRIVIDHA BODHYA SANGRAHA A CROSS-SECTIONAL OBSERVATIONAL STUDY
|
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR GEETANJALI KALLIMATH |
| Designation |
2ND YEAR PG SCHOLAR DPT OF ROGA NIDANA EVAM VIKRUTI VIJNYANA |
| Affiliation |
SDM COLLEGE OF AYURVEDA UDUPI |
| Address |
OPD AND IPD OF DEPARTMENT OF PRASUTI TANTRA EVUM STREEROGA SDM COLLEGE OF AYURVEDA HOSPITAL AND RESEARCH CENTRE KUTHPADY UDUPI KARNATAKA 574118 INDIA OPD AND IPD OF DEPARTMENT OF PRASUTI TANTRA EVUM STREEROGA SDM COLLEGE OF AYURVEDA HOSPITAL AND RESEARCH CENTRE KUTHPADY UDUPI KARNATAKA 574118 INDIA Udupi KARNATAKA 574118 India |
| Phone |
7022212987 |
| Fax |
|
| Email |
geetanjalikallimath59@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR PRASANNA N MOGASALE |
| Designation |
PROFESSOR |
| Affiliation |
SDM COLLEGE OF AYURVEDA HOSPITAL AND RESEARCH CENTER |
| Address |
DEPARTMENT OF PG AND PHD STUDIES IN ROGA NIDANA EVAM VIKRUTI VIJNYANA SDM COLLEGE OF AYURVEDA HOSPITAL AND RESEARCH CENTER KUTHPADY DEPARTMENT OF PG AND PHD STUDIES IN ROGA NIDANA EVAM VIKRUTI VIJNYANA SDM COLLEGE OF AYURVEDA HOSPITAL AND RESEARCH CENTER KUTHPADY Udupi KARNATAKA 574118 India |
| Phone |
9845212813 |
| Fax |
|
| Email |
pnmogasale73@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR GEETANJALI KALLIMATH |
| Designation |
2ND YEAR PG SCHOLAR |
| Affiliation |
SDM COLLEGE OF AYURVEDA UDUPI |
| Address |
DEPARTMENT OF PG AND PHD STUDIES IN ROGA NIDANA EVAM VIKRUTI VIJNYANA SDM COLLEGE OF AYURVEDA HOSPITAL AND RESEARCH CENTER KUTHPADY UDUPI DEPARTMENT OF PG AND PHD STUDIES IN ROGA NIDANA EVAM VIKRUTI VIJNYANA SDM COLLEGE OF AYURVEDA HOSPITAL AND RESEARCH CENTER KUTHPADY UDUPI Udupi KARNATAKA 574118 India |
| Phone |
7022212987 |
| Fax |
|
| Email |
geetanjalikallimath59@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR GEETANJALI KALLIMATH |
| Address |
SHRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA, HOSPITAL AND RESEARCH CENTER UDUPI 574118 KARNATAKA INDIA |
| 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 GEETANJALI KALLIMATH |
SDM College of Ayurveda Hospital and Research Centre Kuthpady Udupi |
OPD-1 AND IPD OF DEPARTMENT OF PRASUTI TANTRA EVUM STREEROGA SDM COLLEGE OF AYURVEDA HOSPITAL AND RESEARCH CENTRE KUTHPADY UDUPI KARNATAKA Udupi KARNATAKA |
7022212987
geetanjalikallimath59@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTE SDM COLLEGE OF AYURVEDA UDUPI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N800||Endometriosis of uterus. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Patients of diagnosed cases of Endometriosis as per diagnostic criteria.
The Women aged 20-40 years will be selected.
Subject having ability and willingness to sign the written informed consent.
Clinically diagnosed cases of Endometriosis based on ICD-11 Diagnosis Code GA-10.
|
|
| ExclusionCriteria |
| Details |
Pregnancy, pelvic inflammatory disease, uterine fibroids, or malignancies.
Patients with known autoimmune disorders (HIV, malignancy etc)
Sexually transmitted disease along with systemic illness.
Surgically diagnosed endometriosis.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ASSESSMENT OF THE STUDY WILL BE DONE ON DIAGNOSED PATIENTS OF ENDOMETRIOSIS, THROUGH AYURVEDA DIAGNOSTIC PRINCIPLE TRIVIDHA BODHYA SANGRAHA LIKELIHOOD. |
ASSESSMENT OF THE STUDY WILL BE DONE ON DIAGNOSED PATIENTS OF ENDOMETRIOSIS, THROUGH AYURVEDA DIAGNOSTIC PRINCIPLE TRIVIDHA BODHYA SANGRAHA LIKELIHOOD. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
01/04/2026 |
| 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
|
ENDOMETRIOSIS IS A CHRONIC GYNECOLOGICAL
CONDITION CHARACTERIZED BY THE PRESENCE OF FUNCTIONING ENDOMETRIAL TISSUE
OUTSIDE THE UTERINE CAVITY, COMMONLY AFFECTING WOMEN OF REPRODUCTIVE AGE AND
PRESENTING WITH SYMPTOMS SUCH AS PELVIC PAIN, DYSMENORRHEA, AND INFERTILITY.
DESPITE ADVANCES IN MODERN MEDICAL AND SURGICAL MANAGEMENT, RECURRENCE AND
PERSISTENT SYMPTOMS REMAIN COMMON CHALLENGES. AYURVEDA EMPHASIZES UNDERSTANDING
DISEASES THROUGH FUNDAMENTAL DIAGNOSTIC PRINCIPLES RATHER THAN RELYING SOLELY
ON DISEASE NOMENCLATURE. ONE SUCH CONCEPT IS TRIVIDHA BODHYA SANGRAHA, WHICH
INCLUDES SAMUTTHANA VISHESHA (ETIOLOGICAL FACTORS), ADHISTHANA ANTARANI (SITE
AND PATHOLOGICAL INVOLVEMENT INCLUDING DOSHA, DHATU, AND SROTAS), AND VIKARA
PRAKRITI VISHESHA (CLINICAL MANIFESTATIONS).THIS CROSS-SECTIONAL OBSERVATIONAL
STUDY AIMS TO EVALUATE ENDOMETRIOSIS THROUGH THE AYURVEDIC DIAGNOSTIC FRAMEWORK
OF TRIVIDHA BODHYA SANGRAHA. WOMEN AGED 20–40 YEARS DIAGNOSED WITH
ENDOMETRIOSIS BASED ON IMAGING CRITERIA WILL BE INCLUDED FROM THE OPD AND IPD
OF SDM AYURVEDA HOSPITAL, UDUPI. A STRUCTURED PROFORMA INCORPORATING DETAILED
HISTORY, CLINICAL EXAMINATION, AND AYURVEDIC DIAGNOSTIC PARAMETERS WILL BE USED
TO ASSESS PATIENTS. THE STUDY INTENDS TO ANALYZE ETIOLOGICAL FACTORS, PATHOLOGICAL
INVOLVEMENT, AND CLINICAL PRESENTATION IN ORDER TO ESTABLISH A POSSIBLE
AYURVEDIC DIAGNOSTIC UNDERSTANDING OF ENDOMETRIOSIS. THE FINDINGS MAY HELP IN
DEVELOPING AN INTEGRATIVE DIAGNOSTIC PERSPECTIVE AND PROVIDE A FOUNDATION FOR
FUTURE PREVENTIVE AND THERAPEUTIC STRATEGIES. |