Efficacy of Nigella Sativa (Nisatol®) in Women With Borderline Blood Pressure Values or a Non-Dipper Blood Pressure Phenotype

March 20, 2026 updated by: Dr. Amjad Khan, Liaquat University of Medical & Health Sciences

Efficacy of Nigella Sativa (Nisatol®) Supplementation in Women With Borderline Blood Pressure Values or a Non-Dipper Blood Pressure Phenotype: A Randomized Placebo-Controlled Study With Dietary Intervention Phase

This randomized placebo-controlled study evaluates the efficacy of Nigella sativa (Nisatol®) supplementation in women with borderline blood pressure values or a non-dipper blood pressure phenotype. The study aims to assess the effects of supplementation on blood pressure and resting heart rate in women presenting high-normal blood pressure values (≥130/85 mmHg) and/or a nocturnal non-dipper blood pressure pattern.

Participants will be randomly assigned to receive either Nigella sativa (Nisatol®) or placebo for 12 weeks. After the treatment phase, a washout period will be followed by a dietary intervention phase combined with alternate treatment according to the study design. Cardiological and nutritional assessments will be performed at predefined time points.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Hypertension represents one of the main risk factors for cardiovascular diseases, which remain the leading cause of mortality worldwide. In women, cardiovascular risk is often underestimated, resulting in lower adherence to preventive screening and frequent presentation at more advanced stages of cardiovascular disease.

Many women present borderline blood pressure values or altered circadian blood pressure patterns, such as the non-dipper phenotype. These conditions may be associated with increased cardiovascular risk and may significantly affect quality of life, particularly in women experiencing climacteric symptoms.

Nigella sativa (black cumin seed) has attracted increasing interest as a nutraceutical strategy for improving cardiovascular and metabolic health. Preliminary evidence suggests that supplementation with Nigella sativa may have beneficial effects on blood pressure, lipid profile, and heart rate.

This randomized controlled trial will evaluate the efficacy of Nigella sativa (Nisatol®) supplementation compared with placebo in women with borderline blood pressure values and/or a non-dipper blood pressure phenotype. Participants will be randomly assigned to either the intervention group receiving Nisatol® or a control group receiving placebo using formulations that are visually indistinguishable.

The initial treatment phase will last 12 weeks. After this phase, treatment will be discontinued and participants will undergo a washout period. Following the washout period, participants will begin a dietary intervention based on a standardized Mediterranean diet combined with the alternate treatment according to the study design.

Participants will be evaluated at predefined time points (baseline, 4 weeks, 12 weeks, and final evaluation) to monitor blood pressure, resting heart rate, adherence to treatment, and potential adverse events. Additional assessments will include lipid profile, fasting blood glucose, body composition parameters, gut microbiota analysis, urinary metabolite analysis, and quality-of-life evaluation using validated questionnaires.

The results of this study are expected to provide additional evidence regarding the potential role of Nigella sativa supplementation as a nutraceutical strategy for improving cardiovascular parameters and metabolic health in women with borderline blood pressure values.

Study Type

Interventional

Enrollment (Estimated)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Female participants
  • High-normal blood pressure values (≥130/85 mmHg) or mild hypertension (140/90 mmHg) with low cardiovascular risk and no current indication for pharmacological therapy
  • Presence of a non-dipper blood pressure phenotype on 24-hour ambulatory blood pressure monitoring
  • Absence of antihypertensive pharmacological treatment Exclusion Criteria
  • History of cardiovascular disease
  • Diabetes mellitus
  • Severe chronic diseases
  • Use of medications affecting blood pressure or heart rate
  • Known allergy to Nigella sativa or fennel

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nisatol®
Participants randomized to this arm will receive Nigella sativa extract (Nisatol®) capsules (2 capsules per day, one capsule in the morning and one in the evening) for 12 weeks.
Dietary supplement: Nigella sativa (Nisatol®)
Standardized Nigella sativa extract (Nisatol®) administered orally 2 capsules per day (one capsule in the morning and one in the evening) for 12 weeks.
Placebo Comparator: Placebo
Participants randomized to this arm will receive placebo capsules identical in appearance to the Nisatol® capsules (2 capsules per day, one capsule in the morning and one in the evening) for 12 weeks.
Other: Placebo
Placebo capsules identical in appearance to the Nigella sativa (Nisatol®) 2 capsules per day administered for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in systolic blood pressure (mmHg)
Time Frame: Baseline to Week 12
Assessment of the change in systolic blood pressure measured in mmHg between baseline and Week 12 in women with high-normal systolic blood pressure values (≥130 mmHg) and/or a nocturnal non-dipper hypertension phenotype.
Baseline to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in diastolic blood pressure (mmHg)
Time Frame: Baseline to Week 12
Assessment of the change in diastolic blood pressure measured in mmHg between baseline and Week 12 in women with high-normal diastolic blood pressure values (≥85 mmHg) and/or a nocturnal non-dipper hypertension phenotype.
Baseline to Week 12
Change in resting heart rate (beats per minute)
Time Frame: Baseline to Week 12
Assessment of the change in resting heart rate measured in beats per minute (bpm) between baseline and Week 12 in women presenting climacteric symptoms and/or resting heart rate above 80 bpm.
Baseline to Week 12
Change in total cholesterol (mg/dL)
Time Frame: Baseline to Week 12
Assessment of the change in total cholesterol concentration measured in mg/dL between baseline and Week 12
Baseline to Week 12
Change in LDL cholesterol (mg/dL)
Time Frame: Baseline to Week 12
Assessment of the change in low-density lipoprotein (LDL) cholesterol concentration measured in mg/dL between baseline and Week 12.
Baseline to Week 12
Change in HDL cholesterol (mg/dL)
Time Frame: Baseline to Week 12
Assessment of the change in high-density lipoprotein (HDL) cholesterol concentration measured in mg/dL between baseline and Week 12.
Baseline to Week 12
Change in triglycerides (mg/dL)
Time Frame: Baseline to Week 12
Assessment of the change in triglyceride concentration measured in mg/dL between baseline and Week 12.
Baseline to Week 12
Change in fasting blood glucose (mg/dL)
Time Frame: Baseline to Week 12
To assess the effect of Nigella sativa supplementation on fasting blood glucose levels.
Baseline to Week 12
Change in urinary metabolite concentrations
Time Frame: Baseline to Week 12
To evaluate the effect of Nigella sativa supplementation on urinary metabolites.
Baseline to Week 12
Change in gut microbiota composition assessed by 16S rRNA sequencing
Time Frame: Baseline to Week 12
To evaluate the effect of Nigella sativa supplementation on gut microbiota composition.
Baseline to Week 12
Change in quality of life assessed by validated questionnaire (SF-36)
Time Frame: Baseline to Week 12
To analyze the impact of the intervention on quality of life using validated questionnaires, with stratification according to menopausal status.
Baseline to Week 12
Change in body weight (kg)
Time Frame: Baseline to Week 12
Assessment of the change in body weight measured in kilograms between baseline and Week 12.
Baseline to Week 12
Change in body fat percentage (%)
Time Frame: Baseline to Week 12
Assessment of the change in body fat percentage between baseline and Week 12.
Baseline to Week 12
Change in basal metabolic rate (kcal/day)
Time Frame: Baseline to Week 12
Assessment of the change in basal metabolic rate measured in kilocalories per day between baseline and Week 12.
Baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liaquat University of Medical & Health Sciences

Collaborators

University of Rome Tor Vergata

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 30, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 16, 2026

First Submitted That Met QC Criteria

March 20, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 20, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 97-2023/20.04.2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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