Antihypertensive Effects of Rosmarinus Officinalis L. Infusion

NCT07386210 | Completed

• 1 other identifier: ROhypertension
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

Brief 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). 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

Keywords

Rosmarinus officinalis L; male hypertensive patients; hypertension; infusion

Outcome Measures

Primary Outcomes (1)

• 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

  6 weeks

Secondary Outcomes (3)

• Determination of serm angiotensin-converting enzyme activity

  6 weeks

• Biochemical Analysis and Assessment

  6 weeks

• Evaluation Perceived Benefits of Rosemary infusion

  6 weeks

Other Outcomes (1)

• Binding affinity of rosemary phenolic compounds to hypertension target proteins assessed by molecular docking

  15 days

Study Arms (2)

Bras 1 rosemary infusion

EXPERIMENTAL

Infusion prepared from 2g of rosemary leaves. Administered orally, 1 cup (100 mL) per day. Duration: 6 weeks.

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

Dietary Supplement: Placebo

Interventions

Rosemary extract infusion DIETARY_SUPPLEMENT

Infusion prepared from 2g of rosemary leaves Administered orally, 1 cup (100 mL) per day Duration: 6 weeks

Bras 1 rosemary infusion

Placebo DIETARY_SUPPLEMENT

Infusion with color and taste similar to rosemary, without active extract Administered orally, 1 cup (100 mL) per day Duration: 6 weeks

bras 2: placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: men with mild hypertension
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• awatef Sassi: lead

Study Sites (2)

Faculty of Medicine of Sousse

Sousse, 4023, Tunisia

Location

Sassi

Sousse, Tunisia

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PHD Assistant Professor at the Private Higher Institute of Nursing Sciences

Study Record Dates

• First Submitted: January 11, 2026
• First Posted: February 4, 2026
• Study Start: March 20, 2023
• Primary Completion: August 28, 2025
• Study Completion: August 29, 2025
• Last Updated: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)