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CTRI Number  CTRI/2022/09/045856 [Registered on: 26/09/2022] Trial Registered Prospectively
Last Modified On: 28/09/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Diagnostic
Preventive
Screening
Behavioral 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study
Modification(s)  		 Effect of Ayurvedic herbal medicine in Heart Failure 
Scientific Title of Study   To evaluate the effect of Ayurvedic Drug Hridya Mahakashaya in Patients with Heart failure with reduced Ejection fraction(AYURVEDA-HF) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vaidya Sushil Kumar Dubey 
Designation  Assistant Professor 
Affiliation  Banaras Hindu University 
Address  Department of Kriya Sharir, Faculty of Ayurveda, IMS, Banaras Hindu University Varanasi.

Varanasi
UTTAR PRADESH
221005
India 
Phone  9415540732  
Fax    
Email  vaidyaskd@bhu.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Suyash Tripathi 
Designation  Assistant Professor 
Affiliation  Banaras Hindu University 
Address  Department of Cardiology, Faculty of Modern Medicine, IMS, Banaras Hindu University Varanasi.

Varanasi
UTTAR PRADESH
221005
India 
Phone  8887496469  
Fax    
Email  suyashtri@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Suyash Tripathi 
Designation  Assistant Professor 
Affiliation  Banaras Hindu University 
Address  Department of Cardiology, Faculty of Modern Medicine, IMS, Banaras Hindu University Varanasi.

Varanasi
UTTAR PRADESH
221005
India 
Phone  8887496469  
Fax    
Email  suyashtri@gmail.com  
 
Source of Monetary or Material Support  
Institute of Eminence(IoE), Banaras Hindu University,Varanasi  
 
Primary Sponsor  
Name  Institute of Eminence IoE 
Address  Banaras Hindu University Varanasi 
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 Suyash Tripathi  Sir Sundar Lal Hospital  Department of Cardiology, Institute of Medical Sciences, Room no- 19, Banaras Hindu University
Varanasi
UTTAR PRADESH 		 8887496469

suyashtri@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition:I420||Dilated cardiomyopathy. Ayurveda Condition: Hridya Roga,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Standard allopathic care and Medication. Evaluating the effect of drug Hridya Mahakashay given in powder form 3 to 5 grams thrice daily, in addition to standard allopathic care, compared with standard allopathic heart failure medications
2Intervention ArmDrugClassical(1) Medicine Name: Hridya Mahakashay, Reference: Charak Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 24 Months, anupAna/sahapAna: Yes(details: cow milk/water), Additional Information: Evaluating the effect of drug Hridya Mahakashay given in powder form 3 to 5 grams thrice daily, in addition to standard allopathic care, compared with standard allopathic heart failure medications.
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Men and women aged 18 years or older with a diagnosis of heart failure for at least 2 months are eligible if they are fulfilling the criteria described in New York Heart Association functional class II or above, have a left ventricular ejection fraction documented to be ≤ 40% within the last 12 months.
2. Patients must have a N‐terminal pro B‐type natriuretic peptide concentration ≥ 600 pg/mL
OR if hospitalised for heart failure within the previous 12 months, ≥ 400 pg/mL.
3. Patients with atrial fibrillation
OR atrial flutter must have a level ≥ 900 pg/mL, irrespective of history of heart failure hospitalization.
4.Provide written informed consent for participation in the study. 
 
ExclusionCriteria 
Details  1. Recent Acute coronary syndrome within 3 months.
2. Recent coronary revascularization within 3 months.
3. Implantation of a CRT device within 12 weeks prior to enrolment or intent to implant a CRT
device
4. Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
5. HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy, or uncorrected primary valvular disease
6. Symptomatic bradycardia or second or third‐degree heart block without a pacemaker
7. Any condition outside the cardiovascular and renal disease area, such as but not limited to malignancy, with a life expectancy of & lt; 2 years based on investigator's clinical
judgement
8. Active malignancy requiring treatment at the time of Visit 1(with the exception of successfully treated basal cell or treated squamous cell carcinoma)
9. Hepatic impairment (aspartate transaminase or alanine transaminase > 3 × the ULN, or total bilirubin > 2 × ULN at time of enrolment). An isolated increase in bilirubin in patients with known Gilbert's syndrome is not a reason for exclusion
10. Known blood‐borne diseases representing a shipping/transportation biohazard
11. Women of child‐bearing potential (i.e. those who are not chemically or surgically sterilized or who are not post‐menopausal) who are not willing to use a medically accepted method of contraception that is considered reliable in the judgement of the investigator, from the time of signing the informed consent throughout the study and 4 weeks thereafter, or women who have a positive pregnancy test at enrolment or randomization, or women who are breast‐feeding
12. Participation in another clinical study with an IP during the last month prior to enrolment
13. Inability of the patient, in the opinion of the investigator, to understand and/or comply
with study medications, procedures and/or follow‐up, or any conditions that, in the opinion of the investigator, may render the patient unable to complete the study. 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Centralized 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
To determine whether Drug Hridya Mahakashay is superior to placebo, when added to standard of care, in reducing the incidence of CV death or a HF event.  24 months 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the effect of Drug Hridya Mahakashay vs. placebo on total number of recurrent HF hospitalizations and CV death.  24 months 
 
Target Sample Size   Total Sample Size="1248"
Sample Size from India="1248" 
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/ Phase 4 
Date of First Enrollment (India)   27/09/2022 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 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)?  

Response - NO
Brief Summary   The title of this research trial is " To evaluate the effect of Ayurvedic Drug Hridya Mahakashaya in Patients with Heart failure with reduced Ejection fraction(AYURVEDA-HF)". For this trial diagnosed cases of heart failure will be registered from OPD of Cardiology, Sir Sundar Lal Hospital, BHU, Varanasi after taking consent. The study is a double blind, parallel group, event driven single center randomized to patients with chronic heart failure, evaluating the effect of drug Hridya Mahakashay given in powder form 3 to 5 grams thrice daily, in addition to standard allopathic care, compared with standard allopathic heart failure medications , on the primary composite outcome of a worsening heart failure events (hospitalization or equivalent event, i.e. an urgent heart failure visit) or cardiovascular death. Patient will be also examined by Ayurvedic Nadi Pariksha ( pulse examination) and also by Nadi Tarangini machine . 
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