CTRI Number |
CTRI/2025/03/083114 [Registered on: 21/03/2025] Trial Registered Prospectively |
Last Modified On: |
18/03/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Case Control Study |
Study Design |
Other |
Public Title of Study
|
Tongue examination in patients of Hemorrhoids disease. |
Scientific Title of Study
|
AN OBSERVATIONAL STUDY OF JIHWA PARIKSHA IN ARSHA WITH SPECIAL REFERENCE TO HEMORRHOIDS. |
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 Darshan Sakariya |
Designation |
PG Scholar |
Affiliation |
Parul Institute Of Ayurved |
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 |
7096433089 |
Fax |
|
Email |
sakariyadarshan5@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Mrunal bhoir |
Designation |
Associate Professor |
Affiliation |
Parul Institute Of Ayurved |
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 Darshan Sakariya |
Designation |
PG Scholar |
Affiliation |
Parul Institute Of Ayurved |
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 |
7096433089 |
Fax |
|
Email |
sakariyadarshan5@gmail.com |
|
Source of Monetary or Material Support
|
PARUL INSTITUTE OF AYURVED,P.O.LIMDA,TALUKA WAGHODIA,DIST-VADODARA,PINCODE-391760,GUJARAT |
|
Primary Sponsor
|
Name |
PARUL INSTITUTE OF AYURVED |
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 Darshan Sakariya |
Parul Ayurved Hospital,Khemdas Ayurved Hospital,Parul Sevashram Hospital,Camp |
OPD ward no.106 (department of Shalyatantra), IPD ward no. 301,302,309,310 (department of Shalyatantra) Parul Ayurved Hospital, Parul University, P.O. Limda, Tal. Waghodia, Dist. Vadodara, Gujrat. Vadodara GUJARAT Vadodara GUJARAT |
7096433089
sakariyadarshan5@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee (IEC)PARUL INSTITUTE OF AYURVED PARUL UNIVERSITY |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:K649||Unspecified hemorrhoids. Ayurveda Condition: ARSAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
1) Selection of patients or healthy individuals will be done irrespective of socioeconomic status.
2) The healthy individuals between the age of 20 to 70 years will be taken for study in group A (control group)
Mails
3) The diagnosed patients with Lakshanas of Arsha(Hemorrhoids) between the age of 20 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.
metalls
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. |
|
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 Arsha(Hemorrhoids) |
4 weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
To use the collected data for upgradation of mobile application |
18 months |
|
Target Sample Size
|
Total Sample Size="300" Sample Size from India="300"
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
|
To conduct Jihwa Pariksha in Healthy individuals and in patients of Arsha with special reference to
Hemorrhoids. To study changes in Jihwa manifested in Healthy individuals and in patients of
Arsha with special reference to Hemorrhoids. No previous much work has been done till date regarding the study of Jihwa Pariksha in Arsha. So its an effort
to go through this particular topic and find out changes in the tongue in Roga like Arsha . So that early diagnosis followed by prone treatment can be suggested. To understand the changes happening
in Jihwa by its examination in Arsha by machine learning technique in imaging. To date, there has been limited research on the examination of Jihwa Pariksha in the context of Arsha. This
study is an earnest endeavor to delve into this specific topic, aiming to identify changes in the tongue associated
with conditions like Arsha. The goal is to facilitate early diagnosis, enabling timely and appropriate treatment recommendations.
Employing machine learning techniques in imaging, this study seeks to comprehend the alterations in Jihwa
during Arsha. In a previous study that explored Jihwa in the context of Purishvaha Srotodushti Vikar, where Arsha was also
included, certain findings were observed. These included fissures and tongue coating in Vataja Arsha and a dominant coating in Kaphaja Arsha, though
the sample size was deemed inadequate. This current study, specifically focusing on changes in Jihwa due to Arsha, aims to address these limitations
and contribute to early diagnosis in a more comprehensive manner. The previous study had some limitations, as it was centered on a single srotas with numerous vyadhis, making
it challenging to focus on individual diseases. It would be more beneficial to conduct a study using a single tongue criteria and to investigate each disease
individually, considering a larger sample size. The tongue serves as a reflection of the internal processes within the body, providing insights into the overall
status of digestion, nutrition, and metabolism. Examining the tongue is a simple yet essential aspect of assessing
the Sama, Nirama, Vriddhi, Kshaya conditions of doshas, and identifying SrotogatVikaras in the diagnosis of
diseases. |