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NCT07494279Not yet recruiting

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

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

Source: ClinicalTrials.gov · Last updated 27 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
106 (estimated)
First submitted
16 Mar 2026
Start date
30 Mar 2026
Primary completion date
30 Nov 2026
Lead sponsor
Liaquat University of Medical & Health Sciences
NCT number
NCT07494279

What you commit to

  • Study type: Interventional
  • Planned participants: 106
  • From 30 Mar 2026 to the primary completion date, 30 Nov 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • 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

Age in the registry: 18 years to 65 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Rome Tor Vergata
Coordinator of this site? Confirm its status
RomaItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.