Clinical trial NCT03909945: Evaluation of an Antihypertensive Food Supplement Based on Aqueous Extract From Annona Muricata Sheets
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hypertension
Keywords: Annona muricata
Hypertension
Sub saharan Africa
Lead sponsor: Yaounde Central Hospital
Sponsor class: OTHER_GOV
First posted: 2019-04-10
Enrollment: 21
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Before and after study intervention
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Variation of the 24-hour systolic blood pressure (mmHg)
timeFrame: 60 days
Secondary outcomes:
measure: Variation in diurnal and nocturnal blood pressure (mmHg)
timeFrame: 60 days
measure: Variation in lipids profile (Triglycerides, HDL-cholesterol, LDL-cholesterol, Total cholesterol) on g/L
timeFrame: 60 days
measure: Variation on serum creatinine (mg/L) and transaminases (SGOT/SGPT) profiles (UI/L)
timeFrame: 60 days
Other outcomes:
Locations:
city: Yaoundé
country: Cameroon
facility: Yaounde Central Hospital, Cardiology department
Study officials:
affiliation: Yaounde Central Hospital
name: Chris Nadege NGANOU-GNINDJIO, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References: