NCT06141200

NW Roselle in Grade 1 Essential Hypertension: Phase III Clinical Trial

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 286 (estimated)
• Sponsor: Natural Wellness Egypt · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Hypertension is a major risk factor for heart, brain, and kidney diseases, and is a leading cause of death and illness globally. Natural Wellness has developed NW Roselle®, a powdered medicinal product that combines extracts from Hibiscus Sabdariffa (HS) flowers and Olea europaea (OE) leaves. In this Phase III clinical trial, researchers are evaluating the efficacy and safety of NW Roselle, in the treatment of Grade 1 essential hypertension. Eligible participants who meet the criteria will be enrolled and randomized in a 1:1 ratio. They will be assigned to receive either NW Roselle or an active control, Captopril 25 mg twice daily. Before the treatment begins, participants will provide informed consent and undergo assessments to collect information about their medical history, hypertension status, lifestyle factors, and demographics. Throughout the trial, the participant's vital signs, physical exams, and laboratory tests will be conducted to monitor their health and response to the treatment. Adherence to the assigned treatment will be monitored, and any potential adverse events or side effects will be tracked.

Conditions

• Essential Hypertension

Interventions

Type	Name	Description
DRUG	NW Roselle	NW Roselle is a powdered extract from the flowers of Hibiscus Sabdariffa (300mg) and the leaves of Olea europaea (200 mg).
DRUG	Captopril 25Mg Tab	Active Comparator

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-04-01
• Completion: 2025-04-01
• First posted: 2023-11-21
• Last updated: 2023-11-21