Status:
UNKNOWN
NW Roselle in Grade 1 Essential Hypertension: Phase III Clinical Trial
Lead Sponsor:
Natural Wellness Egypt
Conditions:
Essential Hypertension
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 Sa...
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 produc...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
286 Patients enrolled
Trial Details
Trial ID
NCT06141200
Start Date
March 1 2024
End Date
April 1 2025
Last Update
November 21 2023
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