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

NCT03909945 | Completed Phase 2

• 1 other identifier: ANNOMUPRIL
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Annona muricata; Hypertension; Sub saharan Africa

Outcome Measures

Primary Outcomes (1)

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

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

  60 days

Secondary Outcomes (3)

• Variation in diurnal and nocturnal blood pressure (mmHg)

  60 days

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

  60 days

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

  60 days

Study Arms (1)

Interventional arm

EXPERIMENTAL

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.

Dietary Supplement: Annona muricata

Interventions

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

Interventional arm

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Side effects affecting life quality of patients (determined by the Data Safety and Monitoring Board).
• Out of sight.
• Withdrawal of consent

Sponsors & Collaborators

• Yaounde Central Hospital: lead

Study Sites (1)

Yaounde Central Hospital, Cardiology department

Yaoundé, Cameroon

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Chris Nadege NGANOU-GNINDJIO, MD, MAS

  Yaounde Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr, Principal investigator

Model Details: Before and after study intervention

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: April 10, 2019
• Study Start: January 1, 2018
• Primary Completion: April 30, 2018
• Study Completion: June 30, 2018
• Last Updated: April 10, 2019

Record last verified: 2019-04

Locations

CA (1)