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

NCT07494279 | Not Yet Recruiting DMC

• 1 other identifier: 97-2023/20.04.2023
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Prehypertension; Hypertension

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (13)

• Change in diastolic blood pressure (mmHg)

  Baseline to Week 12

• Change in resting heart rate (beats per minute)

  Baseline to Week 12

• Change in total cholesterol (mg/dL)

  Baseline to Week 12

• Change in LDL cholesterol (mg/dL)

  Baseline to Week 12

• Change in HDL cholesterol (mg/dL)

  Baseline to Week 12

Study Arms (2)

Nisatol®

EXPERIMENTAL

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®)

Placebo

PLACEBO COMPARATOR

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

Interventions

Nigella sativa (Nisatol®) DIETARY_SUPPLEMENT

Standardized Nigella sativa extract (Nisatol®) administered orally 2 capsules per day (one capsule in the morning and one in the evening) for 12 weeks.

Nisatol®

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Liaquat University of Medical & Health Sciences: lead
• University of Rome Tor Vergata: collaborator

Study Sites (1)

University of Rome Tor Vergata

Roma, Italy

Location

MeSH Terms

Conditions

Prehypertension; Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study is double-blind. Participants, care providers, investigators, and outcome assessors will be unaware of the treatment allocation. Nisatol® capsules and placebo capsules will be identical in appearance, packaging, and labeling to maintain blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomly assigned to receive either Nigella sativa extract (Nisatol®) or placebo for the duration of the intervention. The study follows a parallel-group design in which participants remain in their assigned group throughout the study period.

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 27, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

IT (1)