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CTRI Number  CTRI/2025/03/081955 [Registered on: 07/03/2025] Trial Registered Prospectively
Last Modified On: 30/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To check the effectiveness of Cardorium Plus on Patients with Heart Failure. 
Scientific Title of Study   An Open-Label Clinical Study to Evaluate the Efficacy and Safety of Cardorium Plus (Licensed Ayurvedic Drug) as an Adjunct to Standard Modern Medicine in Subjects with Cardiomyopathy (Heart Failure). 
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 Pradeep Kumar K 
Designation  Consultant cardiologist 
Affiliation  Rajalakshmi Hospital 
Address  Cardiology department, Room no-02 Ground floor. 21/1, Lakshmipura main road, Vidyaranyapura(P), Bangalore-560097.

Bangalore
KARNATAKA
560097
India 
Phone  7022932345  
Fax    
Email  drpradeepkumark6@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Hasan Ali Ahmed 
Designation  Director 
Affiliation  Xplora Clinical Research Services Pvt. Ltd. 
Address  Room No-01,Third floor. #252, 13th cross, Wilson garden,bangalore-560027.

Bangalore
KARNATAKA
560027
India 
Phone  9886012598  
Fax    
Email  hasan@xplorahealth.com  
 
Details of Contact Person
Public Query  
Name  Mr Manik Chaudhuri 
Designation  Project Manager 
Affiliation  Xplora Clinical Research Services Pvt. Ltd. 
Address  Room no-03, Third floor. #252, 13th cross, Wilson garden, bangalore-560027.

Bangalore
KARNATAKA
560027
India 
Phone  9738651205  
Fax    
Email  manik@xplorahealth.com  
 
Source of Monetary or Material Support  
Alakananda Herbals Pvt. Ltd. Plot No. C1. Block III, Beside Hertage Dairy, Uppal IDA. Hyderabad-5600039  
 
Primary Sponsor  
Name  Alakananda Herbals Pvt. Ltd. 
Address  Plot No. C1. Block III, Beside Hertage Dairy, Uppal IDA. Hyderabad-5600039 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Pradeep Kumar K  Rajalakshmi Hospital  Cardiology department, Room no-02, Ground floor. 21/1, Lakshmipura main road, Vidyaranyapura(P), Bangalore-560097.
Bangalore
KARNATAKA 		 7022932345

drpradeepkumark6@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RAJALAKSHMI HOSPITAL INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:I427||Cardiomyopathy due to drug and external agent. Ayurveda Condition: HRUDROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Cardorium Plus, Reference: NA, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator Arm (Non Ayurveda)-Standard of treatmentThe comparator arm patient will be on the standard of treatment.
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) Participants of either sex aged 18 to 65 years.
2) Participants diagnosed with type 2 diabetes for at least 5
years.
3) Participants with clinical and echocardiographic diagnosis of
diabetic cardiomyopathy with left ventricular ejection fraction
(LVEF) less than 45%.
4) Participants with BMI between 18 and 35 kg/m².
5) Participants with HbA1c levels between 6.5 and 12 at
screening.
6) Stable medication for diabetes and heart failure for at least 3
months prior to enrolment.
7) Agrees to not participate in any other clinical trials during the
course of this trial.
8) Willing to participate in the study and provide informed Consent. 
 
ExclusionCriteria 
Details  1) History of significant coronary artery disease, recent
myocardial infarction, or coronary revascularization within 6
months.
2) Uncontrolled hypertension or heart failure requiring
hospitalization in the past 6 months.
3) Individuals with known allergies to any component of the
study products.
4) Subjects with severe liver or kidney disease.
5) Breastfeeding and pregnant women or women planning for a
pregnancy.
6) Participation in another investigational drug trial within the
last 30 days.
7) Unwillingness to comply with study procedures 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
a) Change from baseline in left ventricular ejection fraction (LVEF)
after 12 Weeks, post treatment with Cardorium Plus, accessed
via echocardiography and echocardiogram. 		 Day 1 to Day 90 
 
Secondary Outcome  
Outcome  TimePoints 
a) Change in New York Heart Association (NYHA) classification of
heart failure symptoms.
b) Changes in serum levels of hs-CRP from baseline.
c) Changes in serum levels of HbA1c, and lipid profile (LDL, HDL,
triglycerides).
d) Change from baseline in haematological (CBC) parameters, liver
(SGPT and SGOT) and kidney function (Sr. Creatinine)
parameters.
e) Change from baseline in vital signs (pulse rate, respiratory rate,
blood pressure, and body temperature).
f) Improvement in Quality of Life (QoL) score using KCCQ.
g) Incidence of adverse events (AEs) and serious adverse events
(SAEs) during the study. 		 Day 1 to Day 90 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   17/03/2025 
Date of Study Completion (India) 02/04/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 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   Cardiomyopathy, a heterogeneous group of myocardial disorders, is characterized by structural and functional abnormalities in the heart muscle that may lead to progressive heart failure, arrhythmias, or sudden cardiac death. The etiology of cardiomyopathy is multifactorial, including hypertensive, diabetic, viral, and drug-induced origins, which complicate its diagnosis and management. Hypertensive cardiomyopathy, resulting from chronic pressure overload due to systemic hypertension, induces left ventricular hypertrophy and subsequent diastolic dysfunction. Viral cardiomyopathy, often triggered by viral myocarditis, involves direct viral injury or immune-mediated damage to the myocardium. Drug-induced cardiomyopathy, on the other hand, is an increasingly recognized cause, stemming from cardiotoxic effects of chemotherapeutic agents, recreational drugs, or other pharmacological substances. Cardorium Plus, a licensed Ayurvedic formulation, is known for its cardioprotective properties, including anti-inflammatory, antioxidant, and lipid-modulating effects. By integrating Cardorium Plus as an adjunct to standard care of modern treatment. The primary objective is to evaluate the efficacy of Cardorium Plus in improving left ventricular function (LVEF %) and reducing symptoms of heart failure in subjects with Cardiomyopathy (Hypertensive, Diabetic, Viral and Drug induced). The primary outcome is Change from baseline in left ventricular ejection fraction (LVEF) after 12 Weeks, post treatment with Cardorium Plus, accessed via echocardiography and echocardiogram. The secondary outcome is change in New York Heart Association (NYHA) classification of heart failure symptoms, hs-CRP, HbA1c, lipid profile (LDL, HDL, triglycerides), CBC, liver (SGPT and SGOT), Sr. Creatinine parameters. change from baseline in vital signs, improvement in Quality of life (QoL) score using the Kansas City Cardiomyopathy Questionnaire (KCCQ), Incidence of adverse events (AEs) and serious adverse events (SAEs) during the study. 
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