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CTRI Number  CTRI/2024/07/070457 [Registered on: 11/07/2024] Trial Registered Prospectively
Last Modified On: 06/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Non-randomized, Placebo Controlled Trial 
Public Title of Study   Role of Hridya Mahakashaya churna in Hridroga (CHF) patients 
Scientific Title of Study   Evaluation of Hridya Mahakashaya churna in Hridroga (CHF)and its relation with Prakriti and Agnibala  
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 Ragini Joshi 
Designation  M.D(Ay)Scholar 
Affiliation  Banaras Hindu University 
Address  Department of Kriya Sharir Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  8218923791  
Fax    
Email  raginijoshi2905@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vaidya Sushil Dubey 
Designation  Assistant Professor 
Affiliation  Banaras Hindu University 
Address  Department of Kriya Sharir Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  9415540732  
Fax    
Email  vaidyaskd@bhu.ac.in  
 
Details of Contact Person
Public Query  
Name  Vaidya Sushil Dubey 
Designation  Assistant Professor 
Affiliation  Banaras Hindu University 
Address  Department of Kriya Sharir Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  9415540732  
Fax    
Email  vaidyaskd@bhu.ac.in  
 
Source of Monetary or Material Support  
Department of Kriya Sharir, IMS,Banaras Hindu University, Varanasi 221005 India 
 
Primary Sponsor  
Name  Dr Ragini Joshi 
Address  Department of Kriya Sharir, Faculty of Ayurveda, Institute of Medical Sciences,Banaras Hindu University, 221005, Varanasi, India 
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 Ragini Joshi  Sir Sunderlal Hospital IMS BHU.  OPD of Cardiology, OPD of Kriya Sharir and Kayachikitsa OPD ,Sir Sunderlal Hospital IMS BHU.
Varanasi
UTTAR PRADESH 		 8218923791

raginijoshi2905@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE BANARAS HINDU UNIVERSITY INSTITUTE OF MEDICAL SCIENCES VARANASI INDIA 221005  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:I502||Systolic (congestive) heart failure. Ayurveda Condition: HRUDROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Hridya Mahakashaya, Reference: Charak Samhita Sutra Sthana Chapter 4, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: tds, Bhaishajya Kal: Antarabhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: Patient will be informed about follow up and asked to come with reports.
2Comparator Arm (Non Ayurveda)-Guidelines Directed Medical Therapy as per ESC 2021 Guidelines• ANTI PLATELETS • STATINS • RAAS INHIBITORS • Beta BLOCKERS • SGLT2 INHIBITORS • ALDOSTERONE SYNTHASE INHIBITORS • SOLUBLE GUANYLATE CYCLASE INHIBITOR
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Subjects of either sex belonging to age between 40 to 60 years ,diagnosis of heart failurefor at least 2 months are eligible, if they are fulfilling the criteria described in New York Heart Association (NYHA) functional class II or class III i.e mild or moderate patients,have a left ventricular ejection fraction documented to be ≤ 40% within the last 12 months are taken.
Volunteers willing to be the part of the study by giving written consent in prescribed format.
 
 
ExclusionCriteria 
Details  The patients with age below 40 years and above 60 years.
Patients coming under the criteria described in New York Heart Association (NYHA) functional class IV i.e severe patients of heart failure
Patients with known case of Myocadial Infaction (MI)
Volunteers having any type of recurrent or chronic illness
History of any known disease/illness, tuberculosis, malignancy, severe anemia or any other acute disease.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The effect of Hridya Mahakashaya on Hridroga patients has relation with Prakriti and Agnibala.
And it will assessed by Objective parameters like Electrocardiogram, Echocardiogram of patients on the follow ups and by subjective parameters like filling the standard proforma for prakriti and agnibala before and after the intervention.
 		 Evaluation will be done after 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
The prevalence of Hridroga depend upon the Prakriti & Agnibala of an individual.it will be assessed by filling valid proforma for prakriti & agnibala before the intervention in the patients.   3 months 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   22/07/2024 
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="0"
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   Patients will be randomly divided into two groups. GROUP A (TRIAL) – will be given powder (churna) from 3 grams thrice daily with luke warm water in addition to standard allopathic care.  GROUP B (CONTROL) – given standard allopathic heart failure medications.Treatment Period – First 3 Months ,with medication. Follow up period –  every 1 month.  Another 3 months, post-medication follow up. 
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