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

Condition(s) studied

Investigational drug(s) / intervention(s)

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: Placebo capsules identical in appearance to the Nigella sativa (Nisatol®) 2 capsules per day administered for 12 weeks.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Change in systolic blood pressure (mmHg) — 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.

Trial sites (1)

More Liaquat University of Medical & Health Sciences trials in Italy

Other trials for the same condition