| CTRI Number |
CTRI/2025/09/094637 [Registered on: 11/09/2025] Trial Registered Prospectively |
| Last Modified On: |
04/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study to check the use of herbal supplment mixture in preventing heart problems in patients. |
|
Scientific Title of Study
|
A prospective study to evaluate the effectiveness of polyherbal formulation containing Terminalia arjuna and Terminalia chebula on cardiovascular events in patients with pre-existing heart disease. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mahadevamma Lingaiah |
| Designation |
Principal Investigator |
| Affiliation |
CDSIMER, DSU. |
| Address |
Dr. Chandramma Dayananda Sagar Institute of Medical Education and Research.
Department: Deprtment of Cardiology,
Division: Unit - 1
Room: F- Block, 1st Floor - 3A.
Dr. Chandramma Dayananda Sagar Institute of Medical Education and Research.
Department: Deprtment of Cardiology,
Division: Unit - 1
Room: F- Block, 1st Floor - 3A.
Bangalore
KARNATAKA
562112
India |
| Phone |
9035733812 |
| Fax |
|
| Email |
mahadevammalingaiah11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil Kumar H |
| Designation |
Co- Principal Investiagtor |
| Affiliation |
CDSIMER, DSU. |
| Address |
Dr. Chandramma Dayananda Sagar Institute of Medical Education and Research,
Department: General Medicine
Room: F- Block, 1st Floor R - 1
Devision: Unit III.
Dr. Chandramma Dayananda Sagar Institute of Medical Education and Research,
Department: General Medicine
Room: F- Block, 1st Floor R - 1
Devision: Unit III.
Bangalore
KARNATAKA
562112
India |
| Phone |
8310579850 |
| Fax |
|
| Email |
dranilkh1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahadevamma Lingaiah |
| Designation |
Principal Investigator |
| Affiliation |
CDSIMER, DSU |
| Address |
Dr. Chandramma Dayananda Sagar Institute of Medical Education and Research.
Department: Deprtment of Cardiology,
Room: F- Block, 1st Floor - 3A.
Division: Unit - 1.
Dr. Chandramma Dayananda Sagar Institute of Medical Education and Research.
Department: Deprtment of Cardiology,
Room: F- Block, 1st Floor - 3A.
Division: Unit - 1.
Bangalore Rural
KARNATAKA
562112
India |
| Phone |
9035733812 |
| Fax |
|
| Email |
mahadevammalingaiah11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bioqem Botanicals Pvt Ltd. |
|
|
Primary Sponsor
|
| Name |
Bioqem Botanicals Pvt. Ltd. |
| Address |
Sri Nidhi, 9B, 24th Main Rd, 5th Phase, Annaiah Reddy Layout, J. P. Nagar, Bengaluru, Karnataka 560078 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mahadevamma Lingaiah |
Dr. Chandramma Dayananda Sagar Institute of Medical Education and Research |
Dr. Chandramma Dayananda Sagar Institute of Medical Education and Research.
Department: Deprtment of Cardiology,
Room: F- Block, 1st Floor - 3A.
Division: Unit 1
Devarakaggalahalli, Harohalli, Kanakapura Main Rd, Bengaluru South, Karnataka 562112.
Bangalore
KARNATAKA |
9035733812
mahadevammalingaiah11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, CDSIMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I24||Other acute ischemic heart diseases, (2) ICD-10 Condition: I50||Heart failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Polyherbal formulation |
0.06ml/kg body weight as directed by the physician |
| Comparator Agent |
Standard therapy |
Standard therapy as directed by the cardiologist |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) Subjects diagnosed with ischemic heart disease and heart failure |
|
| ExclusionCriteria |
| Details |
1) Pregnant and lactating women
2) Patients on insulin
3) Patients with valvular and congenital heart diseases
4) Patients with history of any previous haemorrhage |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Lipid profile |
A frequency of once every 30 days and four times every 90 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement of functional parameters. |
A frequency of once every 30 days and four times every 90 days. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
25/09/2025 |
| 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="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is being conducted to check the usefulness and safety of a herbal formulation called Cardio Pro (made from Terminalia arjuna and Terminalia chebula) in people who already have heart disease. All participants will continue their usual standard treatment. In addition, some participants will also receive Cardio Pro. The aim is to see whether Cardio Pro can help improve heart health, reduce risk factors, and support recovery without causing major side effects. Participation is voluntary, and all personal details will be kept confidential. Compensation will be given for travel and time. |