Evaluation of an Antihypertensive Food Supplement Based on Aqueous Extract From Annona Muricata Sheets

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Dietary Supplement: Annona muricata


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: Side effects affecting life quality of patients (determined by the Data Safety and Monitoring Board). Out of sight. Withdrawal of consent

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Before and after study intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional arm<br>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. | Dietary Supplement: Annona muricata<br>* Patients with prehypertension or stage 1 hypertension, in dietary measures, will received daily one tablet of 796 mg of aqueous extracts of Annona muricata leaves. During 60 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of the 24-hour systolic blood pressure (mmHg) | Variation of the 24-hour systolic blood pressure adjusted for baseline by using Ambulatory Blood Pressure Monitoring (ABPM) | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation in diurnal and nocturnal blood pressure (mmHg) | Variation of diurnal and nocturnal blood pressure profile adjusted for baseline by using ABPM | 60 days | 
| Variation in lipids profile (Triglycerides, HDL-cholesterol, LDL-cholesterol, Total cholesterol) on g/L | Variation on serum lipids (Triglycerides, HDL-cholesterol, LDL-cholesterol, Total cholesterol) profiles on g/L, adjusted for baseline. By Trinder Method on spectrophotometry. | 60 days | 
| Variation on serum creatinine (mg/L) and transaminases (SGOT/SGPT) profiles (UI/L) | Variation on serum creatinine (mg/L) by Jaffé Method and serum transaminases (SGOT/SGPT) profiles (UI/L)adjusted from baseline. By spectrophotometer. | 60 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Annona muricata, Hypertension, Sub saharan Africa