Hypertension ArterialNCT07386210
Antihypertensive Effects of Rosmarinus Officinalis L. Infusion
A study testing Rosemary extract infusion in people with Hypertension Arterial, run by awatef Sassi at 2 sites in Tunisia.
Trial summary
This study assessed the antihypertensive effect of rosemary tea through a placebo-controlled clinical study, angiotensin-converting enzyme (ACE) inhibition analysis, and in silico evaluation of interactions between rosemary bioactive compounds and the AT1R (Angiotensin II Type 1 Receptor). Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension Arterial
- What is being tested?
- Rosemary extract infusion
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 2 sitesTunisia
- Study dates
- 20 Mar 2023to 29 Aug 2025
- Phase
- Interventional
- 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 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male participants aged 28-65 years
- Mild hypertension, defined as systolic blood pressure (SBP) 140-159 mmHg and/or diastolic blood pressure (DBP) 90-99 mmHg, according to ESC/ESH 2018 guidelines
- No history of chronic diseases
- Not currently taking antihypertensive medications, other drugs, or dietary supplements
- Body mass index (BMI) within the screening range at recruitment
- Provided written informed consent
Who cannot join
- Secondary hypertension
- History of cardiovascular disease, diabetes mellitus, renal failure, autoimmune disease, or major gastrointestinal disorders
- Current use of medications affecting blood pressure
- Extreme body mass index (BMI) values
- Significant dietary changes or irregular physical activity in the previous six months
- Alcohol consumption or use of illicit drugs
- Inability or unwillingness to maintain usual diet and lifestyle during the study
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Antihypertensive Effects of Rosmarinus Officinalis L. Infusion Supplements in Male Patients With Mild Hypertension : A Randomized Double-Blind Placebo-Controlled Study
This study assessed the antihypertensive effect of rosemary tea through a placebo-controlled clinical study, angiotensin-converting enzyme (ACE) inhibition analysis, and in silico evaluation of interactions between rosemary bioactive compounds and the AT1R (Angiotensin II Type 1 Receptor).
A randomized, double-blind, placebo-controlled trial was conducted in 54 male patients with mild hypertension. Participants were assigned to receive either rosemary infusion (n = 27) or placebo (n = 23) for 45 days. Ambulatory blood pressure monitoring wass used to evaluate blood pressure parameters. Serum ACE activity was measured at baseline and after the intervention using FAPGG hydrolysis. Molecular docking simulations were performed using the Dock 4.2 software.
- Conditions
- Hypertension Arterial
- Being tested
- Rosemary extract infusion, Placebo
- Keywords
- Rosmarinus officinalis L, male hypertensive patients, hypertension, infusion
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosemary extract infusionDietary supplement
Infusion prepared from 2g of rosemary leaves
Administered orally, 1 cup (100 mL) per day
Duration: 6 weeks
PlaceboDietary supplement
Infusion with color and taste similar to rosemary, without active extract Administered orally, 1 cup (100 mL) per day Duration: 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Bras 1 rosemary infusion | Experimental | Infusion prepared from 2g of rosemary leaves. Administered orally, 1 cup (100 mL) per day.
Duration: 6 weeks. Receives: Dietary Supplement: Rosemary extract infusion |
| bras 2: placebo | Placebo comparator | Infusion with color and taste similar to rosemary, without active extract
Administered orally, 1 cup (100 mL) per day
Duration: 6 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of ambulatory blood pressure
ABPM was utilized to improve the accuracy of the clinical trial while minimizing the required number of participants. Blood pressure mea- surements were taken at the brachial artery using a Holter SunTech Medical Oscar 2 device (INC S07Air Port Blvd, Suite 117, Morrisville, NC, USA) to monitor BP over a 24-hour period. The device was set to record BP every 30 min during the day and every hour at night. The cuff was placed on the non-dominant arm, enabling the participants to carry on with their normal activities. They were instructed to stay still during cuff inflation.
The sleep and wake times for programming the Holter device were established based on a question asked to the subjects during their visit. These measurements were recorded on Day 0 (D0) and Day 45 (D45) to assess the impact of the rosemary infusion on blood pressure. We assessed the following blood pressure parameters: 24-h, daytime, and nighttime SBP and DBP, mean blood pressure (MBP), heart rate (HR), and nocturnal d
Measured: 6 weeks
Secondary outcomes (3)
Determination of serm angiotensin-converting enzyme activity
Serum angiotensin-converting enzyme (ACE) activity was determined in men with grade 1 hypertension using serum samples collected at baseline and after six weeks of daily consumption of either rosemary infusions or a placebo. It was measured using the ACE Liquid reagent kit (Sentinel Diagnostics, Italy) on an automated clinical chemistry analyzer (Beckman Coulter AU 700, USA). The method is based on the enzymatic hydrolysis of the synthetic substrate FAPGG (furylacryloyl-phenylalanyl-glycyl-glycine). ACE catalyzes the cleavage of FAPGG, resulting in a decrease in absorbance at 340 nm, which is directly proportional to the ACE activity in the sample. Intra- and inter-assay precision coefficient of variation (CV) of the Beckman Coulter AU 700 Sentinel Diagnostics ACE values are 2.6% and 2.9%, respectively at 40 UI/L. The ACE activity measurement exhibits excellent linearity across the range of 5.8 U/L to 120 U/L, ensuring accurate quantification within this interval. Adults' normal ACE
Measured: 6 weeks
Biochemical Analysis and Assessment
Blood samples were collected from the cubital vein of subjects both at baseline and after the study, following a 12-h fasting period. The samples were drawn into three distinct tubes: an EDTA-coated tube, a heparin-coated tube, and a sodium fluoride/potassium oxalate-coated tube. These samples were immediately subjected to centrifugation for 20 min at 3000 rpm, then stored at -80 ◦C until further analysis.
Plasma aliquots were transferred to the biochemistry laboratory for the determination of various biochemical parameters and ionic con- stituents in the blood, including ASAT, ALAT, total bilirubin, direct bilirubin, γ-GT, alkaline phosphatase, cholesterol, triglycerides, HDL, LDL, glucose, urea, creatinine, uric acid, albumin, Na+, and K+. Ana- lyses were conducted at the Biochemistry Department of Farhat Hached Hospital in Sousse using the Unicell DXC 600 Synchron analyzer by Beckman Coulter. LDL cholesterol levels were calculated using the Friedewald formula.
Measured: 6 weeks
Evaluation Perceived Benefits of Rosemary infusion
During the intervention period, participants were instructed to report any noticeable changes in health status associated with the use of rosemary infusion. This approach enabled the investigator to monitor safety and collect subjective observations related to the intervention.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start20 Mar 2023
- Primary completion28 Aug 2025
- Study completion29 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension ArterialStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- awatef Sassi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, awatef Sassi, Faculty of Medicine, Sousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07386210
- Sponsor's protocol ID
- ROhypertension
- Status last verified
- Jan 2026
- First submitted
- 11 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antihypertensive Effects of Rosmarinus Officinalis L. Infusion Supplements in Male Patients With Mild Hypertension : A Randomized Double-Blind Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT07386210
- Acronym / sponsor ID
- ROhypertension
- Conditions
- Hypertension Arterial
- Keywords
- Rosmarinus officinalis L, male hypertensive patients, hypertension, infusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- awatef SassiUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 28 Aug 2025 (actual)
- Study completion
- 29 Aug 2025 (actual)
- First posted
- 4 Feb 2026 (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.
This study assessed the antihypertensive effect of rosemary tea through a placebo-controlled clinical study, angiotensin-converting enzyme (ACE) inhibition analysis, and in silico evaluation of interactions between rosemary bioactive compounds and the AT1R (Angiotensin II Type 1 Receptor).
A randomized, double-blind, placebo-controlled trial was conducted in 54 male patients with mild hypertension. Participants were assigned to receive either rosemary infusion (n = 27) or placebo (n = 23) for 45 days. Ambulatory blood pressure monitoring wass used to evaluate blood pressure parameters. Serum ACE activity was measured at baseline and after the intervention using FAPGG hydrolysis. Molecular docking simulations were performed using the Dock 4.2 software.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bras 1 rosemary infusion | Experimental | Dietary Supplement: Rosemary extract infusionInfusion prepared from 2g of rosemary leaves. Administered orally, 1 cup (100 mL) per day. Duration: 6 weeks. |
| bras 2: placebo | Placebo comparator | Dietary Supplement: PlaceboInfusion with color and taste similar to rosemary, without active extract Administered orally, 1 cup (100 mL) per day Duration: 6 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male participants aged 28-65 years
- Mild hypertension, defined as systolic blood pressure (SBP) 140-159 mmHg and/or diastolic blood pressure (DBP) 90-99 mmHg, according to ESC/ESH 2018 guidelines
- No history of chronic diseases
- Not currently taking antihypertensive medications, other drugs, or dietary supplements
- Body mass index (BMI) within the screening range at recruitment
Key exclusion criteria (7 listed)
- Secondary hypertension
- History of cardiovascular disease, diabetes mellitus, renal failure, autoimmune disease, or major gastrointestinal disorders
- Current use of medications affecting blood pressure
- Extreme body mass index (BMI) values
- Significant dietary changes or irregular physical activity in the previous six months
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 |
|---|---|---|
| Rosemary extract infusionInfusion prepared from 2g of rosemary leaves Administered orally, 1 cup (100 mL) per day Duration: 6 weeks | Dietary supplement | Bras 1 rosemary infusion |
| PlaceboInfusion with color and taste similar to rosemary, without active extract Administered orally, 1 cup (100 mL) per day Duration: 6 weeks | Dietary supplement | bras 2: placebo |
Primary outcome
Measurement of ambulatory blood pressure
Time frame: 6 weeks
ABPM was utilized to improve the accuracy of the clinical trial while minimizing the required number of participants. Blood pressure mea- surements were taken at the brachial artery using a Holter SunTech Medical Oscar 2 device (INC S07Air Port Blvd, Suite 117, Morrisville, NC, USA) to monitor BP over a 24-hour period. The device was set to record BP every 30 min during the day and every hour at night. The cuff was placed on the non-dominant arm, enabling the participants to carry on with their normal activities. They were instructed to stay still during cuff inflation. The sleep and wake times for programming the Holter device were established based on a question asked to the subjects during their visit. These measurements were recorded on Day 0 (D0) and Day 45 (D45) to assess the impact of the rosemary infusion on blood pressure. We assessed the following blood pressure parameters: 24-h, daytime, and nighttime SBP and DBP, mean blood pressure (MBP), heart rate (HR), and nocturnal d
3 secondary outcomes
Determination of serm angiotensin-converting enzyme activity
Time frame: 6 weeks
Biochemical Analysis and Assessment
Time frame: 6 weeks
Evaluation Perceived Benefits of Rosemary infusion
Time frame: 6 weeks
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 4 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Hypertension Arterial
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rosemary extract infusion in people with Hypertension Arterial, run by awatef Sassi at 2 sites in Tunisia.
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 6 inclusion and 7 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 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Tunisia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Measurement of ambulatory blood pressure (time frame: 6 weeks). 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 4 Feb 2026.