NCT03909945

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Yaounde Central Hospital · Other Government
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Annona 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

Timeline

• Start date: 2018-01-01
• Primary completion: 2018-04-30
• Completion: 2018-06-30
• First posted: 2019-04-10
• Last updated: 2019-04-10

Locations

1 site across 1 country: Cameroon