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CTRI Number  CTRI/2019/08/020555 [Registered on: 05/08/2019] Trial Registered Prospectively
Last Modified On: 02/08/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Other 
Public Title of Study   Ayurvedic management of hridaya roga 
Scientific Title of Study   clinical evaluation of the effect of hridyamrita vati with arjuna ksheer paka as anupana in vataja hridya roga w.s.r. stable angina . 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Dhruv Mishra 
Designation  Associate Professor 
Affiliation  Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan 
Address  Patanjali Ayurved college , Haridwar, Uttarakhand
Dr Dhruv Mishra Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Hardwar Patanjali Ayurved College hardwar
Hardwar
UTTARANCHAL
249405
India 
Phone  8449418880  
Fax    
Email  dr.dhruvmishra@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Dhruv Mishra 
Designation  Associate Professor 
Affiliation  Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan 
Address  Patanjali Ayurved College, Haridwar, Uttarakhand
Dr Dhruv Mishra Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Hardwar Patanjali Ayurved College hardwar
Hardwar
UTTARANCHAL
249405
India 
Phone  8449418880  
Fax    
Email  dr.dhruvmishra@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Dhruv Mishra 
Designation  Associate Professor 
Affiliation  Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan 
Address  51 C Nakshtra Vatika Homes Swami Bhumanand Hospital Campus Ranipur Jhal Jwalapur Haridwar Uttarakhand
Dr Dhruv Mishra Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Hardwar Patanjali Ayurved College hardwar
Hardwar
UTTARANCHAL
249405
India 
Phone  8449418880  
Fax    
Email  dr.dhruvmishra@gmail.com  
 
Source of Monetary or Material Support  
Divya Pharmacy Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Hardwar 
 
Primary Sponsor  
Name  Patanjali Ayurved College 
Address  Patanjali Ayurveda Hospital Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan 
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 
Anupama Rai  patanjali ayurved college  Patanjali Ayurveda Hospital , Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar
Hardwar
UTTARANCHAL 
6397986263

rai.41721@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PAC/Institutional Ethics Committee/2017-18/14  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I798||Other disorders of arteries, arterioles and capillaries in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Hridyamrita Vati with Arjuna Ksheerpaka as Anupana   Hridyamritavati with Arjun KsheerPaka - Orally Dose of Medicine:Hridyamritavati- 2 tab Twice a day After meal with 40 ml Arjun ksheerpaka. for 3 cosecutive months, with in 3 followups.  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Pre-diagnosedcase of stable angina.
2. Patients between the age group of 18-65yrs will be selected.
3. Patients irrespective of sex, religion, occupation and chronicity will be selected.

 
 
ExclusionCriteria 
Details  1. Obstructive CAD>80% luminal diameter stenosis in > 1epicardial coronary artery
2. Patient of acute MI(myocardial infarction), DM, coma,
3. Patient of abnormal heart beat.
4. Chest pain due to non-cardiac problems.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Subjective parameters are:
(Ayurveda)
1. Bheda(Tearing pain)
2. Hridayashunyabhava(Numbness)
3. Stambha(Chest congestion)
4. Drava (Palpitations)
5. Shosha(Mukhshosha /dryness of mouth)
(Modern)
1. 6 MWT (6 minute walk test)/ Physical exertion
2. Angina (5min. or Less)
3. Abdominal gas or indigestion feeling
4. Radiating pain- arm, back or others.
5. Relieved by- rest or medicines.
 
just before intervention of hridyamrita vati with arjun ksheer paka as anupana in vataja hridya roga
 
 
Secondary Outcome  
Outcome  TimePoints 
Subjective parameters are:
(Ayurveda)
1. Bheda(Tearing pain)
2. Hridayashunyabhava(Numbness)
3. Stambha(Chest congestion)
4. Drava (Palpitations)
5. Shosha(Mukhshosha /dryness of mouth)
(Modern)
1. 6 MWT (6 minute walk test)/ Physical exertion
2. Angina (5min. or Less)
3. Abdominal gas or indigestion feeling
4. Radiating pain- arm, back or others.
5. Relieved by- rest or medicines.
 
just after intervention of hridyamrita vati with arjun ksheer paka as anupana in vataj hridya roga ( stable angina 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   Phase 3 
Date of First Enrollment (India)   06/08/2019 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   In this trial, we are selecting the patients of vataj hridya roga (stable angina), In which we will do the intervention in one group of 40 patients. We will intervene with ayurvedic management of vataj hridya roga with Hridyamrit vati 2 tab. twice a day with Arjun ksheer paka as anupana for 3 months with 3 followups. Assessment should be done on the basis of assessment criteria done on the basis of pre treatment and post treatment. 
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