Clinical trial NCT06141200: NW Roselle in Grade 1 Essential Hypertension: Phase III Clinical Trial
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Essential Hypertension
Keywords: Grade 1 Hypertension
primary hypertension
hibiscus
olive leaves
medicinal plants
blood pressure
Lead sponsor: Natural Wellness Egypt
Sponsor class: INDUSTRY
First posted: 2023-11-21
Enrollment: 286
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Phase III, Randomized, Parallel, Double-Dummy, Active-Controlled Clinical Trial
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The mean systolic blood pressure
timeFrame: Week 12
measure: The mean diastolic blood pressure
timeFrame: Week 12
Secondary outcomes:
measure: Systolic Blood Pressure Paired Change
timeFrame: Week 12
measure: Diastolic Blood Pressure Paired Change
timeFrame: Week 12
measure: The rate of achieving blood pressure levels of (Systolic < 140 and Diastolic < 90 mmHg) by week 12
timeFrame: Week 12
measure: The rate of achieving systolic blood pressure range (120-130 mmHg) by week 12
timeFrame: Week 12
measure: The rate of achieving diastolic blood pressure range (70 - 80 mmHg) by week 12
timeFrame: Week 12
measure: Compliance Rate
timeFrame: 12 weeks
measure: Adverse events rate
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Elkafrawy N, Younes K, Naguib A, Badr H, Kamal Zewain S, Kamel M, Raoof GFA, M El-Desoky A, Mohamed S. Antihypertensive efficacy and safety of a standardized herbal medicinal product of Hibiscus sabdariffa and Olea europaea extracts (NW Roselle): A phase-II, randomized, double-blind, captopril-controlled clinical trial. Phytother Res. 2020 Dec;34(12):3379-3387. doi: 10.1002/ptr.6792. Epub 2020 Jul 29.
citation: NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in hypertension prevalence and progress in treatment and control from 1990 to 2019: a pooled analysis of 1201 population-representative studies with 104 million participants. Lancet. 2021 Sep 11;398(10304):957-980. doi: 10.1016/S0140-6736(21)01330-1. Epub 2021 Aug 24.
citation: Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, Clement DL, Coca A, de Simone G, Dominiczak A, Kahan T, Mahfoud F, Redon J, Ruilope L, Zanchetti A, Kerins M, Kjeldsen SE, Kreutz R, Laurent S, Lip GYH, McManus R, Narkiewicz K, Ruschitzka F, Schmieder RE, Shlyakhto E, Tsioufis C, Aboyans V, Desormais I; ESC Scientific Document Group. 2018 ESC/ESH Guidelines for the management of arterial hypertension. Eur Heart J. 2018 Sep 1;39(33):3021-3104. doi: 10.1093/eurheartj/ehy339. No abstract available.
citation: Kandzari DE, Mahfoud F, Weber MA, Townsend R, Parati G, Fisher NDL, Lobo MD, Bloch M, Bohm M, Sharp ASP, Schmieder RE, Azizi M, Schlaich MP, Papademetriou V, Kirtane AJ, Daemen J, Pathak A, Ukena C, Lurz P, Grassi G, Myers M, Finn AV, Morice MC, Mehran R, Juni P, Stone GW, Krucoff MW, Whelton PK, Tsioufis K, Cutlip DE, Spitzer E. Clinical Trial Design Principles and Outcomes Definitions for Device-Based Therapies for Hypertension: A Consensus Document From the Hypertension Academic Research Consortium. Circulation. 2022 Mar 15;145(11):847-863. doi: 10.1161/CIRCULATIONAHA.121.057687. Epub 2022 Mar 14.
citation: Abdel-Rahman RF, Hessin AF, Abdelbaset M, Ogaly HA, Abd-Elsalam RM, Hassan SM. Antihypertensive Effects of Roselle-Olive Combination in L-NAME-Induced Hypertensive Rats. Oxid Med Cell Longev. 2017;2017:9460653. doi: 10.1155/2017/9460653. Epub 2017 Oct 22.