PrehypertensionNCT07494279
Efficacy of Nigella Sativa (Nisatol®) in Women With Borderline Blood Pressure Values or a Non-Dipper Blood Pressure Phenotype
A study testing Nigella sativa (Nisatol®) in people with Prehypertension and Hypertension, run by Liaquat University of Medical & Health Sciences at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Prehypertension, Hypertension
- What is being tested?
- Nigella sativa (Nisatol®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteItaly
- Study dates
- 30 Mar 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Severe chronic diseases
- Use of medications affecting blood pressure or heart rate
- Known allergy to Nigella sativa or fennel
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
University of Rome Tor Vergata
Roma
Prof. Laura Di Renzo, PhD, laura.di.renzo@uniroma2.it
About this study
Official 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
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.
Read the detailed 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, 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.
- Conditions
- Prehypertension, Hypertension
- Being tested
- Nigella sativa (Nisatol®), Placebo
- Medical subject headings
- Prehypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboOther
Placebo capsules identical in appearance to the Nigella sativa (Nisatol®) 2 capsules per day administered for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 12
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to Week 12
Change in fasting blood glucose (mg/dL)
To assess the effect of Nigella sativa supplementation on fasting blood glucose levels.
Measured: Baseline to Week 12
Change in urinary metabolite concentrations
To evaluate the effect of Nigella sativa supplementation on urinary metabolites.
Measured: 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.
Measured: 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.
Measured: Baseline to Week 12
Change in body weight (kg)
Assessment of the change in body weight measured in kilograms between baseline and Week 12.
Measured: Baseline to Week 12
Change in body fat percentage (%)
Assessment of the change in body fat percentage between baseline and Week 12.
Measured: 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.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start30 Mar 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrehypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liaquat University of Medical & Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rome Tor Vergata
- Responsible party
- Principal investigator, Dr. Amjad Khan, Liaquat University of Medical & Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07494279
- Sponsor's protocol ID
- 97-2023/20.04.2023
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07494279
- Acronym / sponsor ID
- 97-2023/20.04.2023
- Conditions
- Prehypertension, Hypertension
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Liaquat University of Medical & Health SciencesUniversity, hospital or other
- Collaborators
- University of Rome Tor Vergata
- Study start
- 30 Mar 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Nisatol® | Experimental | Dietary Supplement: Nigella sativa (Nisatol®)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. |
| Placebo | Placebo comparator | Other: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | Nisatol® |
| PlaceboPlacebo capsules identical in appearance to the Nigella sativa (Nisatol®) 2 capsules per day administered for 12 weeks. | Other | Placebo |
Primary outcome
Change in systolic blood pressure (mmHg)
Time frame: 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.
13 secondary outcomes
Change in diastolic blood pressure (mmHg)
Time frame: Baseline to Week 12
Change in resting heart rate (beats per minute)
Time frame: Baseline to Week 12
Change in total cholesterol (mg/dL)
Time frame: Baseline to Week 12
Change in LDL cholesterol (mg/dL)
Time frame: Baseline to Week 12
Change in HDL cholesterol (mg/dL)
Time frame: Baseline to Week 12
Change in triglycerides (mg/dL)
Time frame: Baseline to Week 12
Change in fasting blood glucose (mg/dL)
Time frame: Baseline to Week 12
Change in urinary metabolite concentrations
Time frame: Baseline to Week 12
Change in gut microbiota composition assessed by 16S rRNA sequencing
Time frame: Baseline to Week 12
Change in quality of life assessed by validated questionnaire (SF-36)
Time frame: Baseline to Week 12
Change in body weight (kg)
Time frame: Baseline to Week 12
Change in body fat percentage (%)
Time frame: Baseline to Week 12
Change in basal metabolic rate (kcal/day)
Time frame: Baseline to Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nigella sativa (Nisatol®) in people with Prehypertension and Hypertension, run by Liaquat University of Medical & Health Sciences at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in systolic blood pressure (mmHg) (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.