| CTRI Number |
CTRI/2025/03/083113 [Registered on: 21/03/2025] Trial Registered Prospectively |
| Last Modified On: |
13/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Observing tongue changes in leucorrhoea(white discharge) |
|
Scientific Title of Study
|
AN Observational study of jihwa pariksha in Shweta pradara with special reference to leucorrhoea. |
| 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 Mahima Dudwe |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
Department of PG and Ph.D studies in Roga Nidana Evum Vikriti Vighyan ,Parul Institute of Ayurveda ,Parul University ,P.O. Limda ,Tal. Waghodia, Dist. Vadodara. Vadodara Gujarat 391760 india
Vadodara
GUJARAT
391760
India |
| Phone |
9131721827 |
| Fax |
|
| Email |
dudwemahima@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mrunal Bhoir |
| Designation |
Associate Professor |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
Department of PG and Ph.D studies in Roga Nidana Evum Vikriti Vighyan ,Parul Institute of Ayurveda ,Parul University ,P.O. Limda ,Tal. Waghodia, Dist. Vadodara. Vadodara Gujarat 391760 india
Vadodara
GUJARAT
391760
India |
| Phone |
8793488139 |
| Fax |
|
| Email |
mrunal.bhoir24537@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahima Dudwe |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
Department of PG and Ph.D studies in Roga Nidana Evum Vikriti Vighyan ,Parul Institute of Ayurveda ,Parul University ,P.O. Limda ,Tal. Waghodia, Dist. Vadodara. Vadodara Gujarat 391760 india
Vadodara
GUJARAT
391760
India |
| Phone |
9131721827 |
| Fax |
|
| Email |
dudwemahima@gmail.com |
|
|
Source of Monetary or Material Support
|
| PARUL INSTITUTE OF AYURVEDA, P.O. LIMDA , TALUKA WAGHODIA, DIST- VADODARA , PINCODE-391760,GUJRAT |
|
|
Primary Sponsor
|
| Name |
PARUL INSTITUTE OF AYURVEDA |
| Address |
Department of PG and Ph.D studies in Roga Nidana Evum Vikriti Vighyan ,Parul Institute of Ayurveda ,Parul University ,P.O. Limda ,Tal. Waghodia, Dist. Vadodara. Vadodara Gujarat 391760 india |
| Type of Sponsor |
Private medical college |
|
|
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 Mahima Dudwe |
1)Parul Ayurveda Hospital, 2) Khemdas Ayurveda Hospital, 3) Parul Sevashram Hospital 4) camp.. |
OPD Ward no. 104 (department of striroga evum prasuti tantra) IPD Ward no. 117 (department of striroga evum prasuti tantra) Parul Ayurveda Hospital , Parul University , P.O. Limda , tal. Waghodia , Dist. Vadodara , Gujarat.
Vadodara
GUJARAT |
9131721827
dudwemahima@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE PARUL INSTITUTE OF AYURVEDA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N899||Noninflammatory disorder of vagina, unspecified. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, (2) ICD-10 Condition:N899||Noninflammatory disorder of vagina, unspecified. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1)Selection of patients or healthy individuals will be done irrespective of socioeconomic status.2)The healthy individuals between the age of 18 to 60 years will be taken for study in group A(control group).3)The diagnosed patients with Lakshanas of Shweta Pradara (Leucorrhoea) between the age of 18 to 60 years will be included in Group B (Test Group) |
|
| ExclusionCriteria |
| Details |
1)Patients with local tongue infection and congenital anomalies will be excluded.2)Patient having major ailments of other systems e.g.,CA of any organs,pregnancy,Hepatitis B & C, TB at the time of enrolling the patient. |
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| to assess the colour,coating and fissure,shape/size,texture,type of movement of tongue in healthy individuals and in the patients of Shweta Pradara (leucorrhoea) |
4 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To use the collected data for upgradation of mobile application |
18 Months |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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)
|
25/04/2025 |
| 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="1"
Months="6"
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
|
The aim of this study is to conduct Jihwa Pariksha in Healthy individuals and in patients of Shweta Pradara with special reference to Leucorrhoea . The Objectives are to study changes in Jihwa manifested in Healthy individuals and in patients of Shweta Pradara.Need of the study :No previous much work has been done till date regarding the study of Jihva Pariksha in Shweta pradara. So its an effort to go through this particular topic and find out changes in the tongue in Shweta Pradara. So that early diagnosis followed by prone treatment can be suggested.To understand the changes happening in Jihwa by its examination in Shweta Pradara by machine learning technique in imaging.A previous study of Jihwa in Artavavaha strotodushti vikar where also a part it was found that certain fissures noted predominantly but there is no such specific study in Shweta Pradara . So this study specific to the changes in the Jihwa due to Shweta Pradara only will be an added benefit in early diagnosis. Tongue is a reflection of what is happening inside a body and it reflects the overall digestive, nutritive, and metabolic conditions of body. Tongue examination is an easy and indispensable part to know sama, nirama and vriddhi, kshaya awastha of dosha, finally in the diagnosis of disease. So for diagnosis of Shweta Pradara the tongue examination can be very useful diagnostic tool. In this study, an effort will be made to analyze the changes in Jihwa due to Shweta Pradara and this work will be unique contribution in Ayurveda. |