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

Sponsor

Natural Wellness Egypt (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06141200

Collaborator

(none)

286

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Essential Hypertension	Drug: NW Roselle Drug: Captopril 25Mg Tab	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

286 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A Phase III, Randomized, Parallel, Double-Dummy, Active-Controlled Clinical TrialA Phase III, Randomized, Parallel, Double-Dummy, Active-Controlled Clinical Trial

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2024

Anticipated Primary Completion Date :

Apr 1, 2025

Anticipated Study Completion Date :

Apr 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study Group (Arm 1) The patient will receive NW Roselle capsules 1000 mg and placebo tablets. Patients will take two capsules of NW Roselle and one placebo tablet orally BID on an empty stomach with plenty of water 15 minutes before meals or one hour after meals. A total dose of 2000 mg of NW Roselle will be administered per day.	Drug: NW Roselle NW Roselle is a powdered extract from the flowers of Hibiscus Sabdariffa (300mg) and the leaves of Olea europaea (200 mg).
Active Comparator: Control Group (Arm 2) Captopril 25 mg tablets will be used. The patient will receive placebo capsules and Captopril 25 mg tablets. Patients will take two placebo capsules and one Captopril 25 mg tablet orally BID on an empty stomach with plenty of water 15 minutes before meals or one hour after meals. A total dose of 50 mg of Captopril will be administered per day.	Drug: Captopril 25Mg Tab Active Comparator

Arm

Intervention/Treatment

Experimental: Study Group (Arm 1)

The patient will receive NW Roselle capsules 1000 mg and placebo tablets. Patients will take two capsules of NW Roselle and one placebo tablet orally BID on an empty stomach with plenty of water 15 minutes before meals or one hour after meals. A total dose of 2000 mg of NW Roselle will be administered per day.

Drug: NW Roselle

NW Roselle is a powdered extract from the flowers of Hibiscus Sabdariffa (300mg) and the leaves of Olea europaea (200 mg).

Active Comparator: Control Group (Arm 2)

Captopril 25 mg tablets will be used. The patient will receive placebo capsules and Captopril 25 mg tablets. Patients will take two placebo capsules and one Captopril 25 mg tablet orally BID on an empty stomach with plenty of water 15 minutes before meals or one hour after meals. A total dose of 50 mg of Captopril will be administered per day.

Drug: Captopril 25Mg Tab

Active Comparator

Outcome Measures

Primary Outcome Measures

The mean systolic blood pressure [Week 12]
The mean systolic blood pressure difference between the study arm and the control arm adjusted for baseline blood pressure.
The mean diastolic blood pressure [Week 12]
The mean diastolic blood pressure difference between the study arm and the control arm adjusted for baseline blood pressure.

Secondary Outcome Measures

Systolic Blood Pressure Paired Change [Week 12]
The mean changes in systolic blood pressure between baseline and week 12 within each arm.
Diastolic Blood Pressure Paired Change [Week 12]
The mean changes in diastolic blood pressure between baseline and week 12 within each arm.
The rate of achieving blood pressure levels of (Systolic < 140 and Diastolic < 90 mmHg) by week 12 [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.
The rate of achieving systolic blood pressure range (120-130 mmHg) by week 12 [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.
The rate of achieving diastolic blood pressure range (70 - 80 mmHg) by week 12 [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.
Compliance Rate [12 weeks]
The mean medication compliance rate (%) will be calculated for each subject as: [(Total number of administered doses) / (Expected number of doses)] *100%.
Adverse events rate [12 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosed with grade 1 essential hypertension (Systolic Blood Pressure: 140-159 mmHg, and/or Diastolic Blood Pressure 90-99 mmHg) (Williams et al., 2018).
Not currently taking any medication for hypertension.
Able and willing to provide written informed consent.

Exclusion Criteria:

Pregnant or lactating women.
Patients with BMI > 45 Kg/m2 or BMI < 18 Kg/m2.
Patients with a known history of secondary hypertension (e.g., hyperaldosteronism, pheochromocytoma, renal artery stenosis, Cushing syndrome).
Renal impairment (Estimated Creatinine Clearance (Cr.Cl.) < 30 ml/min as measured by the Cockcroft-Gault formula).
Known Severe hepatic impairment, biliary cirrhosis, or cholestasis.
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.
Participation in other clinical studies within 30 days before screening.
Known or suspected allergy or any contraindications to the trial products.