Efficacy and Safety of Roselle in Patients With Grade 1 Essential Hypertension: A Phase III, Randomized, Double-Blind, Double-Dummy, Active-Controlled Clinical Trial

NW-ROSELLE-572023

In this Phase III clinical trial, researchers evaluate the efficacy and safety of NW Roselle®, a powdered medicinal product developed by Natural Wellness. NW Roselle combines extracts from Hibiscus Sabdariffa (HS) flowers and Olea europaea (OE) leaves. The trial aims to gather evidence on the efficacy and safety of NW Roselle as a potential treatment option for Grade 1 essential hypertension.

2024-03-01

2025-04-01

2025-04-01

Not yet recruiting

Early phase I

286

Inclusion Criteria: 1. Diagnosed with grade 1 essential hypertension (Systolic Blood Pressure: 140-159 mmHg, and/or Diastolic Blood Pressure 90-99 mmHg) (Williams et al., 2018). 2. Not currently taking any medication for hypertension. 3. Able and willing to provide written informed consent. Exclusion Criteria: 1. Pregnant or lactating women. 2. Patients with BMI \> 45 Kg/m2 or BMI \< 18 Kg/m2. 3. Patients with a known history of secondary hypertension (e.g., hyperaldosteronism, pheochromocytoma, renal artery stenosis, Cushing syndrome). 4. Renal impairment (Estimated Creatinine Clearance (Cr.Cl.) \< 30 ml/min as measured by the Cockcroft-Gault formula). 5. Known Severe hepatic impairment, biliary cirrhosis, or cholestasis. 6. Patients with a history of arrhythmias, ischemic heart diseases, obstruction of the outflow tract of the left ventricle (e.g., hypertrophic obstructive cardiomyopathy, and high-grade aortic stenosis), congestive heart failure, valvular disease, myocardial infarction (MI), angina, myocardial revascularization, or cerebrovascular accident (CVA) within 6 months prior to study entry. 7. Participation in other clinical studies within 30 days before screening. 8. Known or suspected allergy or any contraindications to the trial products.

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2023-11-21