Essential HypertensionPhase 3NCT06141200
NW Roselle in Grade 1 Essential Hypertension: Phase III Clinical Trial
A Phase 3 study testing NW Roselle and Captopril 25Mg Tab in people with Essential Hypertension, run by Natural Wellness Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- NW Roselle and Captopril 25Mg Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Apr 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- Essential Hypertension
- Being tested
- NW Roselle, Captopril 25Mg Tab
- Keywords
- Grade 1 Hypertension, primary hypertension, hibiscus, olive leaves, medicinal plants, blood pressure
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NW RoselleDrug
NW Roselle is a powdered extract from the flowers of Hibiscus Sabdariffa (300mg) and the leaves of Olea europaea (200 mg).
Captopril 25Mg TabDrug
Active Comparator
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Captopril 25Mg Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean systolic blood pressure
The mean systolic blood pressure difference between the study arm and the control arm adjusted for baseline blood pressure.
Measured: 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.
Measured: Week 12
Secondary outcomes (7)
Systolic Blood Pressure Paired Change
The mean changes in systolic blood pressure between baseline and week 12 within each arm.
Measured: Week 12
Diastolic Blood Pressure Paired Change
The mean changes in diastolic blood pressure between baseline and week 12 within each arm.
Measured: Week 12
The rate of achieving blood pressure levels of (Systolic < 140 and Diastolic < 90 mmHg) by 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.
Measured: Week 12
The rate of achieving systolic blood pressure range (120-130 mmHg) by 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.
Measured: Week 12
The rate of achieving diastolic blood pressure range (70 - 80 mmHg) by 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.
Measured: Week 12
Compliance Rate
The mean medication compliance rate (%) will be calculated for each subject as: [(Total number of administered doses) / (Expected number of doses)] *100%.
Measured: 12 weeks
Adverse events rate
- The incidence of AEs reported by the patients, summarized by system organ class, severity, and relationship to study intervention, over the course of treatment.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study startMar 2024 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Phase III, Randomized, Parallel, Double-Dummy, Active-Controlled Clinical Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 286 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Natural Wellness Egypt
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141200
- Sponsor's protocol ID
- NW-ROSELLE-572023
- Status last verified
- Nov 2023
- First submitted
- 15 Nov 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32725873NCD 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.
PubMed 34450083Williams 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.
PubMed 30165516Kandzari 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.
PubMed 35286164Abdel-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.
PubMed 29201276
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06141200
- Acronym / sponsor ID
- NW-ROSELLE-572023
- Conditions
- Essential Hypertension
- Keywords
- Grade 1 Hypertension, primary hypertension, hibiscus, olive leaves, medicinal plants, blood pressure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 286 participants (estimated)
- Lead sponsor
- Natural Wellness EgyptIndustry (pharma, biotech, devices)
- Study start
- Mar 2024 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 21 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A Phase III, Randomized, Parallel, Double-Dummy, Active-Controlled Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Study Group (Arm 1) | Experimental | Drug: NW RoselleThe 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. |
| Control Group (Arm 2) | Active comparator | Drug: Captopril 25Mg TabCaptopril 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NW RoselleNW Roselle is a powdered extract from the flowers of Hibiscus Sabdariffa (300mg) and the leaves of Olea europaea (200 mg). | Drug | Study Group (Arm 1) |
| Captopril 25Mg TabActive Comparator | Drug | Control Group (Arm 2) |
Primary outcome
The mean systolic blood pressure
Time frame: 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
Time frame: Week 12
The mean diastolic blood pressure difference between the study arm and the control arm adjusted for baseline blood pressure.
7 secondary outcomes
Systolic Blood Pressure Paired Change
Time frame: Week 12
Diastolic Blood Pressure Paired Change
Time frame: Week 12
The rate of achieving blood pressure levels of (Systolic < 140 and Diastolic < 90 mmHg) by week 12
Time frame: Week 12
The rate of achieving systolic blood pressure range (120-130 mmHg) by week 12
Time frame: Week 12
The rate of achieving diastolic blood pressure range (70 - 80 mmHg) by week 12
Time frame: Week 12
Compliance Rate
Time frame: 12 weeks
Adverse events rate
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Background: PubMed 32725873Elkafrawy 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.
- Background: PubMed 34450083NCD 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.
- Background: PubMed 30165516Williams 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.
- Background: PubMed 35286164Kandzari 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.
- Background: PubMed 29201276Abdel-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.
- Individual participant dataSharing planned: No
Related trials for Essential Hypertension
Recruiting
The Effect of Self-Acupressure on Blood Pressure, Stress, and Well-Being Levels in Individuals With Hypertension
PRIMARY HYPERTENSION
Active, not recruiting
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
Essential (Primary) Hypertension
Recruiting
Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension
Atherosclerosis Cardiovascular Disease
Not yet recruitingObservational study
A Study to Evaluate the Effectiveness and Safety of S-amlodipine-based Monotherapy and Combination Therapy
Hypertension (HTN), Hypertension
Recruiting
Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
Pregnancy-Associated Hypertension, Gestational Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NW Roselle and Captopril 25Mg Tab in people with Essential Hypertension, run by Natural Wellness Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tarek Nassar, MSc (0201001413875, tarek.nassar@mynaturalwellness.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean systolic blood pressure (time frame: Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06141200, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.