| CTRI Number |
CTRI/2025/10/096377 [Registered on: 23/10/2025] Trial Registered Prospectively |
| Last Modified On: |
02/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of Arjun Ksheera Pak and Makardhwaj Vati in Improving Heart Function |
|
Scientific Title of Study
|
CLINICAL EVALUATION OF ARJUN KSHEERA PAK SPRAY DRIED POWDER & MAKARDHWAJ VATI AS AN ADJUNCT TO STANDARD THERAPY IN HEART FAILURE WITH REDUCED LEFT VENTRICULAR EJECTION FRACTION |
| Trial Acronym |
ARJUNA-HF |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amaan Siddiqui |
| Designation |
PG Scholar |
| Affiliation |
Quadra Institute of Ayurveda and Hospital |
| Address |
Opd No 2 Department Of Kaya Chikitsa Quadra Institute Of Ayurveda And Hospital Nh 58 Roorkee Haridwar Road Near Montfort School Roorkee 247667
Hardwar UTTARAKHAND 247667 India
Hardwar
UTTARANCHAL
247667
India |
| Phone |
8755355133 |
| Fax |
|
| Email |
amaan.siddiqui457@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhishek Bhusan Sharma |
| Designation |
Professor |
| Affiliation |
Quadra Institute of Ayurveda and Hospital |
| Address |
OPD No 2 Department Of Kayachikitsa Quadra Institute Of Ayurveda
And Hospital Nh58 Roorkee Haridwar Road Near Montfort School
Roorkee 247667
Hardwar
UTTARAKHAND
247667
India
Hardwar
UTTARANCHAL
247667
India |
| Phone |
9458636020 |
| Fax |
|
| Email |
ayu.abhishek@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhishek Bhusan Sharma |
| Designation |
Professor |
| Affiliation |
Quadra Institute of Ayurveda and Hospital |
| Address |
OPD No 2 Department Of Kayachikitsa Quadra Institute Of Ayurveda
And Hospital Nh58 Roorkee Haridwar Road Near Montfort School
Roorkee 247667
Hardwar
UTTARAKHAND
247667
India
Hardwar
UTTARANCHAL
247667
India |
| Phone |
9458636020 |
| Fax |
|
| Email |
ayu.abhishek@gmail.com |
|
|
Source of Monetary or Material Support
|
| Opd No 2 Department Of Kayachikitsa Quadra Institute Of Ayurveda And Hospital Nh58 Roorkee
Haridwar Road Near Montfort School Roorkee 247667 |
|
|
Primary Sponsor
|
| Name |
Amaan Siddiqui |
| Address |
Opd No 2 Department Of Kayachikitsa Quadra Institute Of Ayurveda
And Hospital Nh 58 Roorkee Haridwar Road Near Montfort School
Roorkee 247667 |
| Type of Sponsor |
Other [[SELF]] |
|
|
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 |
| Amaan Siddiqui |
Quadra Institute of Ayurveda And Hospital Roorkee |
OPD No 2 Department
Of Kayachikitsa Quadra
Institute Of Ayurveda
And Hospital Nh58
Roorkee Haridwar
Road Near Montfort
School Roorkee
247667
Hardwar
UTTARAKHAND
Hardwar
UTTARANCHAL |
08755355133
amaan.siddiqui457@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE QUADRA INSTITUTE OF AYURVEDA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I501||Left ventricular failure, unspecified. Ayurveda Condition: HRUDROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Arjun Ksheer Pak Powder, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: -Water), Additional Information: - Arjun Ksheera Pak will be prepared according to the classical method described in Bhaisajyaratnavali (Ch. 33, V. 11, Hridya Rog Chikitsa) and subsequently converted into powder using the dry heating technique.
-Patients will receive interventional treatment in addition to their standard heart failure therapy. | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Makardhwaj Vati, Reference: Bhaisajyaratnavali Vajikaran Adhyay, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 320(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: -Water), Additional Information: -Patients will receive interventional treatment in addition to their standard heart failure therapy. | | 3 | Comparator Arm (Non Ayurveda) | | - | Standard Heart Failure Therapy | Conventional treatment for heart failure with reduced ejection fraction, as per standard clinical practice. Patients in this arm will not receive Arjun Ksheera Pak or Makardhwaj Vati. |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. 2D echocardiography: Effective ejection fraction between 20% = 40% due to any cardiac pathology.
2. Coronary Artery Disease
3. Cardiomyopathy
4. Age group: 30 years to 65 years |
|
| ExclusionCriteria |
| Details |
1. Pregnancy and lactating mothers
2. Acute MI
3. Significantly elevated Troponin level
4. Valvular Heart disease
5. Congenital Heart disease
6. Within one week of post Coronary artery bypass graft surgery.
7. Decompensated Heart Failure. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To help relief in symptoms of HFrEF |
Follow ups were scheduled at the 28th day first follow up and 56th day second follow up after initiation of the trial and outcome will be assessed at 56th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Provide a alternative & safe treatment for HFrEF |
18 Months |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
05/11/2025 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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 open-label, two-arm randomized controlled trial aims to evaluate the efficacy of Arjun Ksheera Pak spray-dried powder and Makardhwaj Vati as adjuncts to standard therapy in Heart Failure with Reduced Ejection Fraction (HFrEF). Thirty patients aged 30–65 years with classical features of HFrEF will be randomly selected from the OPD and IPD of the Kayachikitsa Department, Quadra Institute of Ayurveda. Participants will be divided into two groups, one receiving conventional treatment and the other receiving conventional plus interventional therapy. The study duration for each patient will be 56 days, and the total study period is 18 months. Assessment will be based on subjective and objective parameters, and the collected data will be statistically analyzed to evaluate clinical efficacy.
|