HypertensionPhase 2/3AM-HTNNCT03909945
Evaluation of an Antihypertensive Food Supplement Based on Aqueous Extract From Annona Muricata Sheets
A Phase 2/3 study testing Annona muricata in people with Hypertension, run by Yaounde Central Hospital at 1 site in Cameroon.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Annona muricata
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteCameroon
- Study dates
- 1 Jan 2018to 30 Jun 2018
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Side effects affecting life quality of patients (determined by the Data Safety and Monitoring Board).
- Out of sight.
- Withdrawal of consent
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read more
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.
Read the 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
- Being tested
- Annona muricata
- Keywords
- Annona muricata, Hypertension, Sub saharan Africa
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Annona muricataDietary 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Annona muricata |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 60 days
Secondary outcomes (3)
Variation in diurnal and nocturnal blood pressure (mmHg)
Variation of diurnal and nocturnal blood pressure profile adjusted for baseline by using ABPM
Measured: 60 days
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.
Measured: 60 days
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.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start1 Jan 2018
- Primary completion30 Apr 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Before and after study intervention
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yaounde Central Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, CN NGANOU-GNINDJIO, MD, MSc, Yaounde Central Hospital
- Investigators
- Chris Nadege NGANOU-GNINDJIO, MD, MAS, Principal investigator, Yaounde Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03909945
- Sponsor's protocol ID
- ANNOMUPRIL
- Acronym
- AM-HTN
- Status last verified
- Apr 2019
- First submitted
- 5 Mar 2019
- Last updated
- 10 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03909945
- Acronym / sponsor ID
- AM-HTN / ANNOMUPRIL
- Conditions
- Hypertension
- Keywords
- Annona muricata, Hypertension, Sub saharan Africa
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Yaounde Central HospitalOther government
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 10 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Before and after study intervention
| Arm | Type | Receives |
|---|---|---|
| Interventional arm | Experimental | Dietary Supplement: Annona muricataThe 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. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Side effects affecting life quality of patients (determined by the Data Safety and Monitoring Board).
- Out of sight.
- Withdrawal of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Annona muricataPatients 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 | Dietary supplement | Interventional arm |
Primary outcome
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)
3 secondary outcomes
Variation in diurnal and nocturnal blood pressure (mmHg)
Time frame: 60 days
Variation in lipids profile (Triglycerides, HDL-cholesterol, LDL-cholesterol, Total cholesterol) on g/L
Time frame: 60 days
Variation on serum creatinine (mg/L) and transaminases (SGOT/SGPT) profiles (UI/L)
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Nadege NGANOU-GNINDJIO, MD, MAS principal investigator
Yaounde Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Annona muricata in people with Hypertension, run by Yaounde Central Hospital at 1 site in Cameroon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cameroon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of the 24-hour systolic blood pressure (mmHg) (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2019.