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

NCT ID: NCT03909945

Last Updated: 2019-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2018-06-30

Brief Summary

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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

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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

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Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Before and after study intervention
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Interventional arm

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.

Group Type EXPERIMENTAL

Annona muricata

Intervention Type 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

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yaounde Central Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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CN NGANOU-GNINDJIO, MD, MSc

Dr, Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chris Nadege NGANOU-GNINDJIO, MD, MAS

Role: PRINCIPAL_INVESTIGATOR

Yaounde Central Hospital

Locations

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Yaounde Central Hospital, Cardiology department

Yaoundé, , Cameroon

Site Status

Countries

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Cameroon

Other Identifiers

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ANNOMUPRIL

Identifier Type: -

Identifier Source: org_study_id

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