Introduction
Cardiovascular diseases (CVDs) are the leading causes of morbidity and mortality in developed countries and are expected to result in over 23.6 million CVD-related deaths worldwide by 2030.[1] The World Health Organization (WHO) defines CVDs as a group of disorders of the heart and/or blood vessels which include hypertension (HT), coronary heart disease (CHD), cerebrovascular disease, peripheral arterial disease (PAD), cardiomyopathies, and heart failure.[2]
Elevated blood pressure, dietary risks, and lipid disorders, mainly hypercholesterolemia, are in terms of prevalence, the top three cardiovascular risk factors in the world.[3]
Lowering plasma cholesterol levels has been proven to significantly decrease the occurrence of coronary artery disease and stroke. Lipid-lowering therapy is the most efficacious approach to primary and secondary prevention of atherosclerotic cardiovascular disease (ASCVD). Lipid-lowering therapy in primary prevention is associated with a reduction in the risk of death from any cause by 11%, CV death by 20%, acute coronary syndrome by 38%, stroke by 17%, unstable CAD by 25% and major CV events by 26%.[4]
Herbs have a significant role to play in both diet and the treatment of diseases. Studies are currently being conducted to determine the lipid-lowering properties of various herbal plants described in Ayurveda texts. Clinical studies also have reported that Ayurvedic herbal medicines are effective in lowering LDL-C.[5]
Terminalia arjuna, commonly known as Arjuna, is a potential cardio protective agent belonging to the Combretaceae family. Many ancient Ayurvedic texts have prescribed it as an effective remedy for various cardiovascular disorders like anginal pain, hypertension, congestive heart failure, and dyslipidemia.[6] Stembark of Arjuna possesses diuretic, inotropic, and chronotropic properties.[7]
In a randomized, double-blind, cross-over study done in 58 male patients with chronic stable angina (class II–III), treatment with 500 mg of 90% alcohol extract of Arjuna 8 hourly, ISMN (40 mg/day), or a matching placebo for 1 week resulted in a significant decrease in the frequency of angina and the need for isosorbide dinitrate.
Improvements in clinical and TMT parameters were observed with both Arjuna and ISMN as compared to placebo.[8]
With the above leads we planned a double-blind comparative clinical study using Vedistry Arjuna + Tablet and Simvastatin.
Materials and methods
Study design
The present study was a randomized, double-blind, comparative clinical trial designed to evaluate the efficacy and safety of Vedistry Arjuna + Tablet and Simvastatin (used as the reference standard) in patients with chronic stable angina (NYHA class II-III), evidence of provocable ischemia on stress test, and hyperlipidemia. Vedistry Arjuna + Tablet was supplied by Charak Pharma Ltd, Mumbai. The study was Carried out at Dr. Neelam Chaturvedis’ Shree Vishwadhatri Ayurved Clinic Mumbai, & Dr. Manoj Pandey, Shree Samarth Clinic, Mumbai India, from January 2024 to June 2024. All procedures were reviewed and approved by Principal Investigator. A total of 390 patients attending the medicine outpatient clinic were evaluated through medical history and physical examination. Patients with secondary hyperlipidemia, alcoholism, or body weight more than 15% above the ideal for their height were excluded from the study. Baseline cholesterol and triglyceride levels were measured. After screening, 300 patients with evidence of provocable ischemia on stress test and serum cholesterol levels exceeding 200 mg/dL or triglyceride levels over 200 mg/dl were selected.
The patients were randomly assigned to two groups using a randomization table: Vedistry Arjuna + Tablet (Group 1, n=150) and Simvastatin (Group 2, n=150). Informed consent was obtained from all participants, who were instructed to adhere to study protocols. Demographic data, detailed case history, including any previous diseases, and medication history were recorded, along with a physical examination.
Safety assessments included Liver Function Tests (LFTs) and Kidney Function Tests (KFTs), conducted on Day 0 and Day 84. Clinical side effects were recorded at each visit, and their nature, severity, and frequency were discussed with the patient. Routine haematological and urine analysis were also performed.