Efficacy and safety of a Unani polyherbal formulation with Telmisartan in Stage-2 essential hypertension: An open-label, randomized, standard controlled clinical study

Abstract

Background

Despite several initiatives, research, and advancement, the prevalence of essential hypertension keeps on increasing globally and its adverse impacts remain a public health concern.

Aim

To assess the efficacy and safety of a Unani polyherbal formulation in patients of Stage-2 hypertension.

Methods

An open-label, randomized, standard controlled clinical study was conducted in the Department of Moalejat, Ayurvedic and Unani Tibbia College Hospital, Karol Bagh, New Delhi, during 2021–2022.

Both male and female patients, aged 18–65 years with systolic blood pressure ≥140 mmHg and ≤180 mmHg or diastolic blood pressure ≥ 90 mmHg and ≤120 mmHg, were enrolled in the study. Test group patients were treated with Unani Polyherbal formulation (1100 mg daily in two divided doses in a capsule form) while control group patients were given Tablet Telmisartan (40 mg) once daily for 3 weeks.

Results

A total of 60 patients of Stage-2 hypertension (30 in test group and 30 in control group) completed the study, out of them 24 patients in the test group and 25 patients in the control group achieved the target Blood Pressure of 120/80 (±10) mmHg. The mean Blood Pressure of test and control group patients at the end of the study was calculated as 132.86/90.06 mmHg and 131.09/91.92 respectively.

Conclusion

The test drug (Unani polyherbal formulation) was well tolerated and found as safe and efficacious as the control drug (Telmisartan).