Hypertension Clinical Trial
— AM-HTNOfficial 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
| Verified date | April 2019 |
| Source | Yaounde Central Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 21 |
| Est. completion date | June 30, 2018 |
| Est. primary completion date | April 30, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 21 Years to 75 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Cameroon | Yaounde Central Hospital, Cardiology department | Yaoundé |
| Lead Sponsor | Collaborator |
|---|---|
| Yaounde Central Hospital |
Cameroon,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Variation in diurnal and nocturnal blood pressure (mmHg) | Variation of diurnal and nocturnal blood pressure profile adjusted for baseline by using ABPM | 60 days | |
| Secondary | Variation in lipids profile (Triglycerides, HDL-cholesterol, LDL-cholesterol, Total cholesterol) on g/L | Variation on serum lipids (Triglycerides, HDL-cholesterol, LDL-cholesterol, Total cholesterol) profiles on g/L, adjusted for baseline. By Trinder Method on spectrophotometry. | 60 days | |
| Secondary | Variation on serum creatinine (mg/L) and transaminases (SGOT/SGPT) profiles (UI/L) | Variation on serum creatinine (mg/L) by Jaffé Method and serum transaminases (SGOT/SGPT) profiles (UI/L)adjusted from baseline. By spectrophotometer. | 60 days |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT04591808 -
Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia
|
Phase 3 | |
| Recruiting |
NCT04515303 -
Digital Intervention Participation in DASH
|
||
| Completed |
NCT05433233 -
Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension
|
N/A | |
| Completed |
NCT05491642 -
A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses
|
Phase 1 | |
| Completed |
NCT03093532 -
A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities
|
N/A | |
| Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
| Recruiting |
NCT05529147 -
The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly
|
||
| Recruiting |
NCT06363097 -
Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
|
||
| Recruiting |
NCT05976230 -
Special Drug Use Surveillance of Entresto Tablets (Hypertension)
|
||
| Completed |
NCT06008015 -
A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fed Conditions in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT05387174 -
Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period
|
N/A | |
| Completed |
NCT04082585 -
Total Health Improvement Program Research Project
|
||
| Recruiting |
NCT05121337 -
Groceries for Black Residents of Boston to Stop Hypertension Among Adults Without Treated Hypertension
|
N/A | |
| Withdrawn |
NCT04922424 -
Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men
|
Phase 1 | |
| Active, not recruiting |
NCT05062161 -
Sleep Duration and Blood Pressure During Sleep
|
N/A | |
| Completed |
NCT05087290 -
LOnger-term Effects of COVID-19 INfection on Blood Vessels And Blood pRessure (LOCHINVAR)
|
||
| Not yet recruiting |
NCT05038774 -
Educational Intervention for Hypertension Management
|
N/A | |
| Completed |
NCT05621694 -
Exploring Oxytocin Response to Meditative Movement
|
N/A | |
| Completed |
NCT05688917 -
Green Coffee Effect on Metabolic Syndrome
|
N/A | |
| Recruiting |
NCT05575453 -
OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure
|
N/A |