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Clinical Trial NCT07494279 for Prehypertension, Hypertension is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Efficacy of Nigella Sativa (Nisatol®) in Women With Borderline Blood Pressure Values or a Non-Dipper Blood Pressure Phenotype 106 Randomized Placebo-Controlled Dietary
Clinical Trial NCT07494279 is an interventional study for Prehypertension, Hypertension and is currently not yet recruiting. Enrollment is planned to begin on March 30, 2026 and continue until the study accrues 106 participants. Led by Liaquat University of Medical & Health Sciences, this study is expected to complete by December 31, 2026. The latest data from ClinicalTrials.gov was last updated on March 27, 2026.
Brief 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.
P...
Show MoreDetailed 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,...
Show MoreOfficial Title
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
Conditions
PrehypertensionHypertensionOther Study IDs
- 97-2023/20.04.2023
NCT ID Number
Start Date (Actual)
2026-03-30
Last Update Posted
2026-03-27
Completion Date (Estimated)
2026-12-31
Enrollment (Estimated)
106
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalNisatol® 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. | 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 ComparatorPlacebo 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. | Placebo Placebo capsules identical in appearance to the Nigella sativa (Nisatol®) 2 capsules per day administered for 12 weeks. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | Baseline to Week 12 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | 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. | 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 | 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. | 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. | 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. | Baseline to Week 12 |
Change in fasting blood glucose (mg/dL) | To assess the effect of Nigella sativa supplementation on fasting blood glucose levels. | Baseline to Week 12 |
Change in urinary metabolite concentrations | 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 | 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) | 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) | Assessment of the change in body weight measured in kilograms between baseline and Week 12. | Baseline to Week 12 |
Change in body fat percentage (%) | Assessment of the change in body fat percentage between baseline and Week 12. | 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. | Baseline to Week 12 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female
- 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
- 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
Liaquat University of Medical & Health SciencesUniversity of Rome Tor VergataStudy Responsible Party
Dr. Amjad Khan, Principal Investigator, Professor, Liaquat University of Medical & Health Sciences
No contact data.
1 Study Locations in 1 Countries
University of Rome Tor Vergata, Roma, Italy
Prof. Laura Di Renzo, PhD, Contact, [email protected]