FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/02/080255 [Registered on: 10/02/2025] Trial Registered Prospectively
Last Modified On: 25/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Study conducted to see the effect of Ayurvedic Formulation as an add-on drug to evaluate lipid profile and ecg changes in the Ischemic Heart Disease 
Scientific Title of Study   Evaluation of Ayurvedic Formulation as an add-on drug in the Ishemic Heart Disease with special reference to Vataj Hridrog 
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 Shweta Patil 
Designation  MD Scholar Kayachikitsa 
Affiliation  Dr D Y Patil College of Ayurved and Research centre 
Address  Department of kayachikitsa, OPD no 5, Dr D Y Patil College of Ayurved Research Centre Sant Tukaram Nager Pimpri Pune Maharashtra

Pune
MAHARASHTRA
411018
India 
Phone  7028361557  
Fax    
Email  shwetapatilbembrekar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Abhijit Shekhar 
Designation  Assistant Professor MD Kayachikitsa  
Affiliation  Dr D Y Patil College of Ayurved and Research centre 
Address  Department of kayachikitsa, OPD 5, Dr D Y Patil College of Ayurved Research Centre,Sant Tukaram Nager Pimpri Pune Maharashtra

Pune
MAHARASHTRA
411018
India 
Phone  9764546495  
Fax    
Email  abhijitshekhar00@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shweta Patil 
Designation  MD Scholar Kayachikitsa 
Affiliation  Dr D Y Patil College of Ayurved and Research centre 
Address  Department of kayachikitsa, OPD no 5, Dr D Y Patil College of Ayurved Research Centre Sant Tukaram Nager Pimpri Pune Maharashtra

Pune
MAHARASHTRA
411018
India 
Phone  7028361557  
Fax    
Email  shwetapatilbembrekar@gmail.com  
 
Source of Monetary or Material Support  
Dr D Y Patil College of Ayurved and Research Centre Sant Tukaram Nager Pimpri Pune Maharashtra 411018 
 
Primary Sponsor  
Name  Dr Shweta Patil 
Address  Dr D Y Patil College of Ayurved and Research Centre Sant Tukaram Nager Pimpri Pune Maharashtra 
Type of Sponsor  Other [Self] 
 
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 Shweta Prakash Patil  Dr.D.Y.Patil College of Ayurved and Research Centre,Pimpri Pune.  Kayachikitsa Department, OPD No.5, Sant Tukaram Nagae, Pimpri, Pune-411018, Maharashtra
Pune
MAHARASHTRA 		 7028361557

shwetapatilbembrekar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
DR.DYPCA RC INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:I00-I99||Diseases of the circulatory system. Ayurveda Condition: VATAJAHRUDROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Ayurvedic formulation, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: warm water), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patient who were pre-diagnosed with Ischemic Heart Disease Vataj Hridrog presenting classical sign and symptoms as Precordial pain (Hridshool including all type of chest pain) Dyspnoea (Shwasavrodha) Palpitation(Hrutdrav) Fatigue(Akasmat dinata) Any two
ECG-ST-Tchanges ST depressionand T wave inversion in anterior wall,lateral,posterior,inferior,septal wall.  
 
ExclusionCriteria 
Details  Acute Myocardial Infraction
Unstable Angina
Pregnant and lactation mother
Known history of hemorrhagic storke
Known history of Positive HIV test Hepatitis B surface antigen
Any other chronic disease

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the Add On effect of Ayurvedic Formulation on Precordial pain (Hridshool including all type chest pain)
Dyspnoea(Shwasavrodha) Palpitation (Hrutdrav) Ftigue (Akasmat dinata) 		 30 Days study with follow up (15,30) 
 
Secondary Outcome  
Outcome  TimePoints 
To assess improvement in ECG-ST-T changes (ST- depression,T wave
inversion) 		 30 Days study with follow up (15,30) 
 
Target Sample Size   Total Sample Size="31"
Sample Size from India="31" 
Final Enrollment numbers achieved (Total)= "31"
Final Enrollment numbers achieved (India)="31" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   11/02/2025 
Date of Study Completion (India) 24/03/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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 the study is to see the efficacy of ayurvedic formulation as an add on drug in the Ischemic heart disease with special reference with vataj hridrog. The study will be conducted on 31 patients having signs and symptoms of ischemic heart disease with special reference with vataj hridrog. 2 tablets of 500mg will be given twice in a day along with luke warm water  before food for the duration of 30 days and follow up will be done on 15th and 30th day and final conclusion will be drawn on the basis of statistical methods.

 
Close