NW Roselle in Grade 1 Essential Hypertension: Phase III Clinical Trial
NCT ID: NCT06141200
Last Updated: 2023-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
286 participants
INTERVENTIONAL
2024-03-31
2025-04-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
NW Roselle
NW Roselle is a powdered extract from the flowers of Hibiscus Sabdariffa (300mg) and the leaves of Olea europaea (200 mg).
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.
Captopril 25Mg Tab
Active Comparator
Interventions
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NW Roselle
NW Roselle is a powdered extract from the flowers of Hibiscus Sabdariffa (300mg) and the leaves of Olea europaea (200 mg).
Captopril 25Mg Tab
Active Comparator
Eligibility Criteria
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Inclusion Criteria
2. Not currently taking any medication for hypertension.
3. Able and willing to provide written informed consent.
Exclusion Criteria
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.
18 Years
65 Years
ALL
No
Sponsors
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Natural Wellness Egypt
INDUSTRY
Responsible Party
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Central Contacts
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References
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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.
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.
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.
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.
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.
Other Identifiers
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NW-ROSELLE-572023
Identifier Type: -
Identifier Source: org_study_id