Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional arm | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Annona muricata | Dietary Supplement | 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 |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Chris Nadege NGANOU-GNINDJIO, MD, MAS | Yaounde Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yaounde Central Hospital, Cardiology department | Yaoundé | Cameroon |
Not provided
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Before and after study intervention
Not provided
Not provided
Not provided
Not provided
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 |