Clinical evaluation of capsule BP Norm in the management of essential hypertension: A preliminary open-label parallel group study

Abstract

Abstract Background: Since hypertension is so common and a major risk factor for cardiovascular illnesses and other complications, it is both a significant public health issue and an important topic of research. Hence, a clinical trial was planned. Aims: To evaluate the role of herbal preparation capsule BP Norm containing dry extract of Bhringraja (Eclipta alba (L) Hassk.), Haritaki (Terminalia chebula Retz.), Ashwagandha (Withania somnifera (L.) Dunal), Shankhpushpi (Convolvulus pluricaulis), and Sarpagandha (Rauwolfia serpentina [L.] Benth. Ex Kurzc) in newly diagnosed cases and in combination with allopathic antihypertensive drugs in the uncontrolled cases of essential hypertension. Materials and methods: A total of 103 patients meeting the seventh report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure criteria of essential hypertension (EHT) of age group 20–65 years of either sex participated in the study. Newly diagnosed cases who were not taking any antihypertensives were administered capsule BP Norm (250 mg), two capsules twice daily for 1 month, whereas uncontrolled cases of essential hypertension (systolic blood pressure [SBP] >140 mmHg and <200 mmHg and/or diastolic blood pressure [DBP] >90 mmHg and <120 mmHg) were administered 1 capsule of BP Norm (250 mg) twice daily with water in addition to continuing allopathic antihypertensive drugs for 1 month. The assessment was made through various variables such as SBP, DBP, chief complaints, associated complaints, Hamilton anxiety rating scale (HARS), Hamilton rating scale for depression (HRSD), lipid profile, and serum creatinine. Results: Capsule BP Norm produced highly significant reduction in both the SBP (16.82%, P < 0.001) and DBP (13.71%, P < 0.001) of newly diagnosed patients as well as in the SBP (18.49%, P < 0.001) and DBP (13.95%, P < 0.001) of uncontrolled cases (EHT). Capsule BP Norm provided significant relief in clinical features of EHT, HARS, and HRSD in both groups. Conclusion: Capsule BP Norm has promising antihypertensive effects in newly diagnosed cases as well as synergistic effects when combined with allopathic antihypertensive drugs in uncontrolled cases of essential hypertension.