Black seed extract shows promise for metabolic syndrome in midlife women
NCT ID NCT07013058
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a black seed extract (Nisatol®) in 50 perimenopausal women with metabolic syndrome, a cluster of conditions like high blood sugar and blood pressure. Over 4 months, researchers measured changes in blood sugar, cholesterol, blood pressure, and menopausal symptoms. The goal was to see if the extract could improve these health markers and quality of life.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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50 people
The number who actually took part.
- Started
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Jun 2025
- Finished
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Dec 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 40 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Perimenopausal women aged 40-60 years * Presence of climacteric (menopausal) symptoms * Diagnosis of metabolic syndrome, defined as alteration of at least 3 of the following: * Systolic blood pressure ≥130 mmHg and/or diastolic ≥85 mmHg * HDL cholesterol \<50 mg/dL * Triglycerides ≥150 mg/dL * Fasting blood glucose ≥100 mg/dL * Uricemia \>7 mg/dL Exclusion Criteria: * Use of hormone replacement therapy (HRT) * Presence of neoplastic diseases * Presence of liver disease, kidney failure, or diabetes mellitus * Drug or alcohol abuse * Known hypersensitivity to Nigella sativa or any formulation component
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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ASL Frosinone, Dipartimento di Prevenzione,
Frosinone, 03100, Italy
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