Evaluation of an Antihypertensive Food Supplement Based on Aqueous Extract From Annona Muricata Sheets (AM-HTN)

Yaounde Central Hospital

Status and phase: Completed; Phase 3; Phase 2

Conditions: Hypertension

Treatments: Dietary Supplement: Annona muricata

Study type: Interventional

Funder types: Other

Identifiers

NCT03909945

ANNOMUPRIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Interventional arm

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Annona muricata