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

NCT06141200 | Unknown Phase 3

• 1 other identifier: NW-ROSELLE-572023
• Study Type: interventional
• Target: 286
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Essential Hypertension

Keywords

Grade 1 Hypertension; primary hypertension; hibiscus; olive leaves; medicinal plants; blood pressure

Outcome Measures

Primary Outcomes (2)

• The mean systolic blood pressure

  The mean systolic blood pressure difference between the study arm and the control arm adjusted for baseline blood pressure.

  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.

  Week 12

Secondary Outcomes (7)

• Systolic Blood Pressure Paired Change

  Week 12

• Diastolic Blood Pressure Paired Change

  Week 12

• The rate of achieving blood pressure levels of (Systolic < 140 and Diastolic < 90 mmHg) by week 12

  Week 12

• The rate of achieving systolic blood pressure range (120-130 mmHg) by week 12

  Week 12

• The rate of achieving diastolic blood pressure range (70 - 80 mmHg) by week 12

  Week 12

Study Arms (2)

Study Group (Arm 1)

EXPERIMENTAL

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

Control Group (Arm 2)

ACTIVE COMPARATOR

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

Interventions

NW Roselle DRUG

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

Study Group (Arm 1)

Captopril 25Mg Tab DRUG

Active Comparator

Control Group (Arm 2)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Natural Wellness Egypt: lead

Related Publications (5)

• 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.

  PMID: 32725873 BACKGROUND

• 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.

  PMID: 34450083 BACKGROUND

• 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.

  PMID: 30165516 BACKGROUND

• 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.

  PMID: 35286164 BACKGROUND

• 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.

  PMID: 29201276 BACKGROUND

MeSH Terms

Conditions

Essential Hypertension

Interventions

Captopril

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Proline; Imino Acids; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Tarek Nassar, MSc

CONTACT

0201001413875; tarek.nassar@mynaturalwellness.com

Sylvia Samir, MSc

CONTACT

0201227919053; researchassociate3@mynaturalwellness.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A Phase III, Randomized, Parallel, Double-Dummy, Active-Controlled Clinical Trial

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: November 21, 2023
• Study Start: March 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share