Rationale and Design of a Single Arm, Non-randomized Open-label Clinical Trial Evaluating a Tablet Made of Aqueous Extract of Annona Muricata in an African Hypertensive Population
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Variation of the 24-hour systolic blood pressure (mmHg)
研究概览
简要总结
The AM-HTN trial aim to investigate the effects of a tablet based on aqueous extracts of Annona muricata as add-on therapy in a hypertensive population.
Patients with prehypertension or stage 1 hypertension confirmed, will be selected and assign in a single arm, non randomly, open label clinical trial.
The group will receive in addition to their dietary measures, daily, one tablet of 796 mg of aqueous extracts of Annona muricata leaves.
The objective of AM-HTN is to determine the antihypertensive and metabolic effects of AM tablets in a population of African hypertensives.
Blood pressure profile, lipid profile, serum creatinine and transaminases profiles will be recorded and analysed at baseline and two months following enrolment.
详细描述
The AM-HTN trial aim to investigate the effects of a tablet based on aqueous extracts of Annona muricata as add-on therapy in a hypertensive population.
Patients with prehypertension or stage 1 hypertension confirmed, will be selected and assign in a single arm, non randomly, open label clinical trial.
The group will receive in addition to their dietary measures, daily, one tablet of 796 mg of aqueous extracts of Annona muricata leaves.
The objective of AM-HTN is to determine the antihypertensive and metabolic effects of AM tablets in a population of African hypertensives.
Blood pressure profile, lipids profile, serum creatinine and transaminases profiles were will be recorded and analysed at baseline and two months following enrolment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Blood pressure between 130/85 mmHg and 159/99 mmHg
- •No antihypertensive therapy (determined by the investigator), except the hygiene dietetic measures, for at least 3 months
- •No history of hepatic or renal insufficiency
- •Before any study-specific procedure, the appropriate written informed consent must be obtained.
排除标准
- •Side effects affecting life quality of patients (determined by the Data Safety and Monitoring Board).
- •Out of sight.
- •Withdrawal of consent
研究组 & 干预措施
Interventional arm
The intervention consisted in the daily administration, during 60 days, of a 796 mg tablet of aqueous extracts of leaves of Annona muricata between 08:00 AM and 09:00 AM.
干预措施: Annona muricata (Dietary Supplement)
结局指标
主要结局
Variation of the 24-hour systolic blood pressure (mmHg)
时间窗: 60 days
Variation of the 24-hour systolic blood pressure adjusted for baseline by using Ambulatory Blood Pressure Monitoring (ABPM)
次要结局
- Variation in diurnal and nocturnal blood pressure (mmHg)(60 days)
- Variation in lipids profile (Triglycerides, HDL-cholesterol, LDL-cholesterol, Total cholesterol) on g/L(60 days)
- Variation on serum creatinine (mg/L) and transaminases (SGOT/SGPT) profiles (UI/L)(60 days)
研究者
CN NGANOU-GNINDJIO, MD, MSc
Dr, Principal investigator
Yaounde Central Hospital