Efficacy of Nigella Sativa (Nisatol®) in Women With Borderline Blood Pressure Values or a Non-Dipper Blood Pressure Phenotype
Starting soon · Not applicable · Has a placebo group
Conditions studied: Prehypertension, Hypertension
In brief
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.
Key facts
- Study ID
- NCT07494279
- Run by
- Liaquat University of Medical & Health Sciences
- People needed
- 106
- Starts
- 2026-03-30
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-03-27
Who can join
Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- University of Rome Tor Vergata — Roma, Italy
Full record on ClinicalTrials.gov
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