Efficacy of Terminalia arjuna in essential hypertension: A randomized controlled study.

OBJECTIVE: Hypertension is still the most prevalent of all non-communicable chronic diseases worldwide. It is the most common risk factor for cardiovascular disease (CVD) burden and mortality. In 2019, hypertension was reported as the number one and two cause of death in women, and men respectively, accounting for almost 20% of deaths globally. In India, 57% of stroke and 24% of coronary heart disease (CHD) deaths are directly related to high blood pressure. To achieve true control over this disorder, novel antihypertensive therapies need to be designed. In light of the current situation, a clinical trial was conducted to evaluate the efficacy of Terminalia arjuna in primary hypertension. METHODS: The present study was a triple-blind randomized placebo-controlled study with 44 patients of stage- 1 primary hypertension of both genders, between 30 and 70 years of age randomly assigned to the control and test group; comprising 22 patients in each group. The test group received Terminalia arjuna at a total daily dose of 3 g, administered orally in capsule form in two divided doses after food (1.5 g twice daily), whereas the control group received a matching placebo in the same manner for 28 days. All participants received standardized background therapy with telmisartan 40 mg once daily, continued unchanged throughout the study. All the participants were assessed on subjective and objective parameters. The results were analyzed statistically. RESULTS: At the end of the study, in both the test and control group, systolic blood pressure (SBP) and diastolic blood pressure (DBP) reduced significantly as compared to baseline (P < 0.001) and (P < 0.001) respectively. The reduction in the test group was statistically significant than the control group (P < 0.001). In the test group, serum cholesterol, serum triglycerides, and very low-density lipoproteins (VLDL) decreased significantly compared to the control group P < 0.01, P = 0.027, and P < 0.01 respectively. Subjective parameters also showed a statistically significant reduction in the test group at the end of the trial. No test drug-related adverse events were observed. CONCLUSION: The results provide evidence that the test drug is beneficial in primary hypertension. The test drug reduced systolic and diastolic blood pressure significantly more than the placebo. CLINICAL TRIAL REGISTRATION NO: CTRI/2022/03/041,534.