Hypertension
Conditions
Keywords
Annona muricata, Hypertension, Sub saharan Africa
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.
Interventions
DIETARY_SUPPLEMENTAnnona muricata
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
Sponsors
Yaounde Central Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Before and after study intervention
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Cameroon
Outcome results
None listed