Efficacy and Safety of Roselle in Patients With Grade 1 Essential Hypertension: A Phase III, Randomized, Double-Blind, Double-Dummy, Active-Controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 286
- 主要终点
- The mean systolic blood pressure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Pregnant or lactating women.
- •Patients with BMI > 45 Kg/m2 or BMI < 18 Kg/m
- •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.
研究组 & 干预措施
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.
干预措施: NW Roselle (Drug)
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.
干预措施: Captopril 25Mg Tab (Drug)
结局指标
主要结局
The mean systolic blood pressure
时间窗: 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
时间窗: Week 12
The mean diastolic blood pressure difference between the study arm and the control arm adjusted for baseline blood pressure.
次要结局
- 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)
- Compliance Rate(12 weeks)
- Adverse events rate(12 weeks)