An interventional study of Nigella sativa (Nisatol®) and Placebo in Prehypertension and Hypertension, sponsored by Liaquat University of Medical & Health Sciences. Not yet recruiting at 1 site in Italy. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Liaquat University of Medical & Health Sciences · Not applicable, Interventional, and Treatment
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.
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.
158 studies on the registry are indexed under Prehypertension; 21 are open to participants now.
This study's planned enrollment of 106 is above the median of 66 across 138 interventional studies indexed under Prehypertension.
Browse Prehypertension studies →Liaquat University of Medical & Health Sciences is the lead sponsor of 55 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria
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®)
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
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 capsules identical in appearance to the Nigella sativa (Nisatol®) 2 capsules per day administered for 12 weeks.
Change in systolic blood pressure (mmHg)
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.
Time frame: Baseline to Week 12
Change in diastolic blood pressure (mmHg)
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.
Time frame: Baseline to Week 12
Change in resting heart rate (beats per minute)
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.
Time frame: Baseline to Week 12
Change in total cholesterol (mg/dL)
Assessment of the change in total cholesterol concentration measured in mg/dL between baseline and Week 12
Time frame: Baseline to Week 12
Change in LDL cholesterol (mg/dL)
Assessment of the change in low-density lipoprotein (LDL) cholesterol concentration measured in mg/dL between baseline and Week 12.
Time frame: Baseline to Week 12
Change in HDL cholesterol (mg/dL)
Assessment of the change in high-density lipoprotein (HDL) cholesterol concentration measured in mg/dL between baseline and Week 12.
Time frame: Baseline to Week 12
Change in triglycerides (mg/dL)
Assessment of the change in triglyceride concentration measured in mg/dL between baseline and Week 12.
Time frame: Baseline to Week 12
Change in fasting blood glucose (mg/dL)
To assess the effect of Nigella sativa supplementation on fasting blood glucose levels.
Time frame: Baseline to Week 12
Change in urinary metabolite concentrations
To evaluate the effect of Nigella sativa supplementation on urinary metabolites.
Time frame: Baseline to Week 12
Change in gut microbiota composition assessed by 16S rRNA sequencing
To evaluate the effect of Nigella sativa supplementation on gut microbiota composition.
Time frame: Baseline to Week 12
Change in quality of life assessed by validated questionnaire (SF-36)
To analyze the impact of the intervention on quality of life using validated questionnaires, with stratification according to menopausal status.
Time frame: Baseline to Week 12
Change in body weight (kg)
Assessment of the change in body weight measured in kilograms between baseline and Week 12.
Time frame: Baseline to Week 12
Change in body fat percentage (%)
Assessment of the change in body fat percentage between baseline and Week 12.
Time frame: Baseline to Week 12
Change in basal metabolic rate (kcal/day)
Assessment of the change in basal metabolic rate measured in kilocalories per day between baseline and Week 12.
Time frame: Baseline to Week 12
Start is estimated for Mar 2026; primary completion for Nov 2026, 8 months later.
Of 56 non-industry interventional studies with no phase under Prehypertension, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 37. This study's planned 8 months is below that.
Counting every sponsor, half of 60 studies reached it within 20 months; a quarter within 11 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Nigella sativa
Liaquat University of Medical & Health Sciences