Efficacy of Cardojith in Adults with Stage 1 Hypertension
Scientific Title of Study
An Randomized Controlled Trial Assessing the Cardioprotective and Antihypertensive Potential of Cardojith in Adults with Stage 1 Hypertension
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
K RAMACHANDRA REDDY
Designation
VICE CHANCELLOR
Affiliation
MGG AYUSH UNIVERSITY, GORAKHPUR
Address
Department of Rasashastra and Bhaishaja Kalpana, Mahayogi Guru Gorakhnath AYUSH University, Gorakhpur, Uttar Pradesh Department of Rasashastra and Bhaishaja Kalpana, Mahayogi Guru Gorakhnath AYUSH University, Gorakhpur, Uttar Pradesh Gorakhpur UTTAR PRADESH 273306 India
Phone
9415813533
Fax
Email
krcreddy@bhu.ac.in
Details of Contact Person Scientific Query
Name
Dr Somit Kumar
Designation
Chief Scientific Officer
Affiliation
The Arya Vaidya Pharmacy (Coimbatore) Limited
Address
Department of Research and Developement, The Arya Vaidya Pharmacy (Coimbatore) Limited, Coimbatore, Tamilnadu
Coimbatore TAMIL NADU 641045 India
Phone
9003856200
Fax
Email
cso@avpresearch.org
Details of Contact Person Public Query
Name
Dr Somit Kumar
Designation
Chief Scientific Officer
Affiliation
The Arya Vaidya Pharmacy (Coimbatore) Limited
Address
Department of Research and Developement, The Arya Vaidya Pharmacy (Coimbatore) Limited, Coimbatore, Tamilnadu
Coimbatore TAMIL NADU 641045 India
Phone
9003856200
Fax
Email
cso@avpresearch.org
Source of Monetary or Material Support
The Arya Vaidya Pharmacy (Coimbatore) Limited
42, Perumal Koil St, Olymbus, Rukmani Nagar, Ramanathapuram, Coimbatore, Tamil Nadu 641045
Primary Sponsor
Name
The Arya Vaidya Pharmacy (Coimbatore) Limited
Address
42, Perumal Koil St, Olymbus, Rukmani Nagar, Ramanathapuram, Coimbatore, Tamil Nadu 641045
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 KRC Reddy
Mahayogi Guru Gorakhnath AYUSH University
Department of Rasashastra and Bhaishaja Kalpana, MGGAU, Pipari, Bhathat, Gorakhpur, Uttar Pradesh 273306 Gorakhpur UTTAR PRADESH
9415813533
krcreddy@bhu.ac.in
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Clinical Ethics Committee Mahayogi Guru Gorakhnath Ayush University
Patients aged 30 to 65 years with mild to moderate essential hypertension were enrolled in this study. Eligibility criteria included a mean sitting diastolic blood pressure greater than or equal to 80 mmHg and less than or equal to 89 mmHg and a mean sitting systolic blood pressure greater than or equal to 130 mmHg and less than or equal to 139 mmHg as measured prior to randomization.
ExclusionCriteria
Details
Patients with secondary or malignant hypertension, structural or functional heart disease within the past six months, cerebrovascular disease within the past six months, uncontrolled diabetes defined as fasting blood glucose greater than 7.8 mmol per liter or glycosylated hemoglobin greater than 7.5 percent, malignant retinopathy, history of mental disorder, history of malignant tumor, alcohol or drug abuse, and those receiving concomitant medications with potential effects on blood pressure or antihypertensive drugs and statins
Method of Generating Random Sequence
Permuted block randomization, fixed
Method of Concealment
Other
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
Change in mean sitting systolic blood pressure (msSBP) and mean sitting diastolic blood pressure (msDBP) from baseline to 8 weeks.
Baseline, 2nd, 4th, 6th and 8th week.
Secondary Outcome
Outcome
TimePoints
Change in msSBP and msDBP from baseline to 2, 4, and 6 weeks of treatment.
baseline to 2, 4, and 6 weeks of treatment
Response assessments after 4 and 8 weeks
Marked response
msDBP decreased by greater than or equal to 10 mmHg and within the normal range, OR msDBP decreased by greater than or equal to 20 mmHg but not within the normal range, OR msSBP decreased by greater than or equal to 30 mmHg.
Response
msDBP decreased by less than 10 mmHg and within the normal range, OR msDBP decreased by 10–19 mmHg but not within the normal range, OR msSBP decreased by greater than or equal to20 mmHg.
Total response rate
Sum of marked response rate and response rate.
4th and 8th weeks
Control rate after 4 and 8 weeks of treatment
proportion of patients with msDBP less than 90 mmHg and msSBP less than 140 mmHg.
4th and 8th week
Reduction in perceived psychological stress, assessed using the Perceived Stress Scale (PSS)
Baseline, 2nd, 4th, 6th and 8th week.
Decrease in high-sensitivity C-reactive protein (hs-CRP) levels
Baseline, 2nd, 4th, 6th and 8th week.
Safety assessment through LFT, RFT and CBC; adverse events categorised according to CTCAE version 4.03 where study specific AE is defined with a severity of grade 3 or more and/or that leads to discontinuation of the study drug.
2nd, 4th, 6th and 8th week.
Target Sample Size
Total Sample Size="75" Sample Size from India="75" 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)
06/12/2025
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="2" Days="15"
Recruitment Status of Trial (Global)
Open to Recruitment
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
Introduction
Cardiovascular diseases (CVD) encompass a range of disorders affecting the heart and blood vessels, including coronary artery disease, cerebrovascular disease, and hypertensive heart disease. CVD remains the leading cause of mortality worldwide, accounting for an estimated 17.9 million deaths each year, which represents approximately 32% of all global deaths [1]. In India, the burden is particularly alarming, with recent estimates indicating that CVD is responsible for over 28% of total deaths, and the age-standardized CVD death rate in India exceeds the global average [2,3].
Hypertension, or persistently elevated blood pressure, is a major modifiable risk factor for CVD and affects approximately 1.28 billion adults globally, of whom nearly 46% are unaware of their condition [4]. In India, the prevalence of hypertension among adults is estimated to range from 25% to 30%, and it often coexists with dyslipidemia, obesity, insulin resistance, and heightened oxidative stress, contributing to the pathogenesis of CVD [5].
Current pharmacological management of hypertension includes antihypertensive drugs such as ACE inhibitors, beta-blockers, calcium channel blockers, and diuretics [6]. While effective, these therapies are often associated with side effects, suboptimal adherence, and a limited impact on comorbid stress, inflammation, and endothelial dysfunction [7]. Consequently, there is a growing interest in integrative and holistic approaches that address multiple mechanistic pathways[8,10].
Cardojith is a polyherbal formulation that comprises botanicals with documented antihypertensive, lipid-lowering, cardiotonic, and adaptogenic activities. These herbs collectively target not only hemodynamic parameters but also oxidative and psychological stress, thereby offering a potentially comprehensive strategy for cardiovascular risk reduction. Given the increasing global burden of hypertension and the limitations of current therapeutic modalities, a scientifically rigorous clinical evaluation of Cardojith is warranted to explore its efficacy and safety as a complementary intervention in hypertensive individuals at risk for cardiovascular events.
Literature review on the proposed intervention
Cardojith is a proprietary polyherbal formulation thoughtfully developed to support cardiovascular function and assist in the management of hypertension. Rooted in the principles of Ayurveda and strengthened by emerging pharmacological evidence, it brings together a synergistic blend of herbs traditionally employed for their cardioprotective, antihypertensive, and antioxidant properties. The formulation includes Terminalia arjuna (Arjuna), Inula racemosa (Pushkarmoola), Commiphora mukul (Guggulu), Allium sativum (Lasuna), and Rauwolfia serpentina (Sarpagandha), each contributing unique and complementary mechanisms of action aimed at restoring vascular balance and cardiac health.
Terminalia arjuna, the cornerstone of this formulation, is widely regarded in classical Ayurvedic texts and modern studies for its cardiotonic properties. It contains bioactive compounds such as flavonoids, tannins, and triterpenoids, which have been shown to improve endothelial function, enhance myocardial contractility, reduce low-density lipoprotein (LDL) cholesterol, and support overall cardiac performance [11]. Inula racemosa exerts cardioprotective effects by mitigating oxidative stress and improving myocardial function, particularly in models of isoproterenol-induced cardiac injury [12]. Commiphora mukul, rich in guggulsterones, contributes anti-inflammatory and lipid-lowering actions, which are crucial in preventing atherosclerosis and vascular inflammation [13].
Allium sativum (garlic), an extensively studied medicinal plant, contributes to vascular health through its sulfur-containing compounds such as allicin. These have been shown to induce vasodilation, inhibit platelet aggregation, and improve lipid profiles—mechanisms that collectively reduce blood pressure and protect against endothelial dysfunction [14]. Rauwolfia serpentina, a time-honored remedy for hypertension, contains reserpine, which acts centrally and peripherally by depleting catecholamines through inhibition of vesicular monoamine transporters. This leads to a sustained reduction in sympathetic tone and blood pressure [15].
By targeting multiple pathophysiological pathways—such as elevated vascular resistance, dysregulated lipid metabolism, sympathetic overactivity, and oxidative stress—Cardojith offers a comprehensive and integrative approach to cardiovascular care. Its multi-targeted mode of action holds promise not only in managing hypertension but also in mitigating associated cardiovascular risks when used alongside conventional therapies.
Rationale
A clinical investigation into the efficacy of Cardojith is justified by the convergence of empirical evidence and pharmacological findings supporting the therapeutic potential of its constituent herbs. Cardiovascular diseases remain the foremost cause of global mortality, driven by modifiable risk factors such as hypertension, dyslipidemia, oxidative stress, and neuroendocrine dysregulation. Despite the availability of pharmacotherapies, there is a persistent need for integrative interventions that target multiple pathophysiological mechanisms. Cardojith, a polyherbal formulation, integrates botanicals known for their cardioprotective, antihypertensive, lipid-modulating, and adaptogenic properties. Given this multi-targeted pharmacodynamic profile, it is imperative to conduct a scientifically rigorous clinical trial to evaluate Cardojith’s role in mitigating cardiovascular risk among hypertensive individuals.
Investigator Team
Principal Investigator
1. Dr K Ramachandra Reddy, Vice-Chancellor, Mahayogi Guru Gorakhnath AYUSH University
Co-Investigators
1. Dr Somit Kumar, Chief Scientific Officer, The Arya Vaidya Pharmacy (Coimbatore) Limited
2. Dr Sindhu, Vice-President, R&D, The Arya Vaidya Pharmacy (Coimbatore) Limited