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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K649||Unspecified hemorrhoids. Ayurveda Condition: ARSAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
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)

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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.

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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.  
 
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