Evaluation of an Antihypertensive Food Supplement Based on Aqueous Extract From Annona Muricata Sheets
- Conditions
- Hypertension
- Interventions
- Dietary Supplement: Annona muricata
- Registration Number
- NCT03909945
- Lead Sponsor
- Yaounde Central Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
- 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.
- Side effects affecting life quality of patients (determined by the Data Safety and Monitoring Board).
- Out of sight.
- Withdrawal of consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Interventional arm Annona muricata 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.
- Primary Outcome Measures
Name Time Method Variation of the 24-hour systolic blood pressure (mmHg) 60 days Variation of the 24-hour systolic blood pressure adjusted for baseline by using Ambulatory Blood Pressure Monitoring (ABPM)
- Secondary Outcome Measures
Name Time Method Variation in diurnal and nocturnal blood pressure (mmHg) 60 days Variation of diurnal and nocturnal blood pressure profile adjusted for baseline by using ABPM
Variation in lipids profile (Triglycerides, HDL-cholesterol, LDL-cholesterol, Total cholesterol) on g/L 60 days Variation on serum lipids (Triglycerides, HDL-cholesterol, LDL-cholesterol, Total cholesterol) profiles on g/L, adjusted for baseline. By Trinder Method on spectrophotometry.
Variation on serum creatinine (mg/L) and transaminases (SGOT/SGPT) profiles (UI/L) 60 days Variation on serum creatinine (mg/L) by Jaffé Method and serum transaminases (SGOT/SGPT) profiles (UI/L)adjusted from baseline. By spectrophotometer.
Trial Locations
- Locations (1)
Yaounde Central Hospital, Cardiology department
🇨🇲Yaoundé, Cameroon