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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
286
NW Roselle is a powdered extract from the flowers of Hibiscus Sabdariffa (300mg) and the leaves of Olea europaea (200 mg).
Active Comparator
The mean systolic blood pressure
The mean systolic blood pressure difference between the study arm and the control arm adjusted for baseline blood pressure.
Time frame: Week 12
The mean diastolic blood pressure
The mean diastolic blood pressure difference between the study arm and the control arm adjusted for baseline blood pressure.
Time frame: Week 12
Systolic Blood Pressure Paired Change
The mean changes in systolic blood pressure between baseline and week 12 within each arm.
Time frame: Week 12
Diastolic Blood Pressure Paired Change
The mean changes in diastolic blood pressure between baseline and week 12 within each arm.
Time frame: Week 12
The rate of achieving blood pressure levels of (Systolic < 140 and Diastolic < 90 mmHg) by week 12
The proportion of patients in each treatment group who are able to achieve the target blood pressure levels of systolic blood pressure \< 140 mmHg and diastolic blood pressure \< 90 mmHg by week 12.
Time frame: Week 12
The rate of achieving systolic blood pressure range (120-130 mmHg) by week 12
The proportion of patients in each treatment group who are able to achieve the target systolic blood pressure range of 120-130 mmHg by week 12.
Time frame: Week 12
The rate of achieving diastolic blood pressure range (70 - 80 mmHg) by week 12
The proportion of patients in each treatment group who are able to achieve the target diastolic blood pressure control of 70-80 mmHg by week 12.
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Time frame: Week 12
Compliance Rate
The mean medication compliance rate (%) will be calculated for each subject as: \[(Total number of administered doses) / (Expected number of doses)\] \*100%.
Time frame: 12 weeks
Adverse events rate
2\. The incidence of AEs reported by the patients, summarized by system organ class, severity, and relationship to study intervention, over the course of treatment.
Time frame: 12 weeks