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CTRI Number  CTRI/2024/12/078645 [Registered on: 27/12/2024] Trial Registered Prospectively
Last Modified On: 26/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study of structural involvement and changes in heart in patients of Pittaj hrudroga. 
Scientific Title of Study   A cross sectional study to find structural involvement and changes in hrudaya in patients of pittaj hrudroga using 2D echocardiography 
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 Ashwini Ramkrushna Pinge 
Designation  Pg Scholar 
Affiliation  PDEAS college of ayurved and research centre 
Address  PDEAS College of ayurved and research centre rachana sharir department, ground floor,room no.1,sector 25,nigdi pune Maharashtra 411044 India
PDEAS College of ayurved and research centre rachana sharir department, ground floor,room no.1,sector 25,nigdi pune Maharashtra 411044 India
Pune
MAHARASHTRA
411044
India 
Phone  9657583084  
Fax    
Email  ashupinge0307@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dinesh Naik 
Designation  Associate Professor 
Affiliation  PDEAS college of ayurved and research centre 
Address  PDEAS College of ayurved and research centre rachana sharir department, ground floor,room no.1,sector 25,nigdi pune Maharashtra 411044 India
PDEAS College of ayurved and research centre rachana sharir department, ground floor,room no.1,sector 25,nigdi pune Maharashtra 411044 India
Pune
MAHARASHTRA
411044
India 
Phone  9145458644  
Fax    
Email  drdineshnaik27@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Dinesh Naik 
Designation  Associate Professor 
Affiliation  PDEAS college of ayurved and research centre 
Address  PDEAS College of ayurved and research centre rachana sharir department, ground floor,room no.1,sector 25,nigdi pune Maharashtra 411044 India
PDEAS College of ayurved and research centre rachana sharir department, ground floor,room no.1,sector 25,nigdi pune Maharashtra 411044 India
Pune
MAHARASHTRA
411044
India 
Phone  9145458644  
Fax    
Email  drdineshnaik27@gmail.com  
 
Source of Monetary or Material Support  
PDEAS college of ayurved and research centre nigdi pune 411044, Maharashtra, India 
 
Primary Sponsor  
Name  Pdea college of ayurved and research centre nigdi pune 
Address  Pdea college of ayurved and research centre sector 25 pradhikaran nigdi pune 411044 
Type of Sponsor  Research institution and hospital 
 
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 Ashwini Ramkrushna Pinge  Ayurved Rugnalaya and sterling and multispeciality hospital nigdi pradhikaran pune  Ayurved Rugnalaya and sterling and multispeciality hospital nigdi pradhikaran pune sector 27 opd no 117 kayachikitsa department Pune MAHARASHTRA
Pune
MAHARASHTRA 		 9657583084

ashupinge0307@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Chairperson Ethics Committe College of Ayurved And Research Centre Akurdi Pune 44  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:I20-I25||Ischemic heart diseases. Ayurveda Condition: HRUDROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1)Prediagnosed patient having symptoms of pittaj hrudroga who
have recent reports of2D echocardiography
2)Age group 25 – 70 years, irrespective of sex, religion,
socioeconomic status and occupation. 
 
ExclusionCriteria 
Details  1)Patient who is suffering from Congenital heart disease.
2)Patient who have undergone coronary artery bypass graft.
3)Patient who have undergone percutaneous transluminal
coronary angioplasty,valvular replacement
4) Known cases of HIV,TB 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To find out structural involvement and changes in
hrudaya in patients of pittaj hrudroga using 2 D
echocardiography. 		 1 time 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="61"
Sample Size from India="61" 
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)   10/01/2025 
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 Yet Recruiting 
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 dosas having undergone morbid increase, vitiate the
rasadhatu localise themselves in the heart causing pain. This condition is known as Hrudroga,The Hridaya as an organ is seem to be structurally affected in many cardiac disorders like myocardial ischemia, myocardial infarction, congestive cardiac failure etc. Thus with the symptoms of pittaj Hridroga, it can best studied that whether Hridaya is structurally affected or not.
 
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