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Completed

NCT Number: NCT03909945

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Yaounde Central Hospital, Cardiology department

Yaoundé, Cameroon

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Variation of the 24-hour systolic blood pressure (mmHg)

    Time frame: 60 days

    Variation of the 24-hour systolic blood pressure adjusted for baseline by using Ambulatory Blood Pressure Monitoring (ABPM)

Secondary outcomes

  1. Variation in diurnal and nocturnal blood pressure (mmHg)

    Time frame: 60 days

    Variation of diurnal and nocturnal blood pressure profile adjusted for baseline by using ABPM

  2. Variation in lipids profile (Triglycerides, HDL-cholesterol, LDL-cholesterol, Total cholesterol) on g/L

    Time frame: 60 days

    Variation on serum lipids (Triglycerides, HDL-cholesterol, LDL-cholesterol, Total cholesterol) profiles on g/L, adjusted for baseline. By Trinder Method on spectrophotometry.

  3. Variation on serum creatinine (mg/L) and transaminases (SGOT/SGPT) profiles (UI/L)

    Time frame: 60 days

    Variation on serum creatinine (mg/L) by Jaffé Method and serum transaminases (SGOT/SGPT) profiles (UI/L)adjusted from baseline. By spectrophotometer.

Sponsors and collaborators

Lead sponsor

Yaounde Central Hospital

Other Gov

Registry information

Official study 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

Acronym: AM-HTN

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 10, 2019
Registry last updated
Apr 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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