CompletedNot Applicable

Evaluation of a Nigella Sativa Extract (10% Thymoquinone, Nisatol®) in Perimenopausal Women With Metabolic Syndrome

Italy50 participantsStarted 2025-06-15

Plain-language summary

A prospective, multicenter, randomized controlled study evaluating the efficacy and safety of a Nigella sativa extract standardized to 10% thymoquinone (Nisatol®) in perimenopausal women with metabolic syndrome. The study will assess changes in metabolic and blood pressure parameters, as well as improvements in menopausal symptoms and quality of life.

Who can participate

Age range18 Years – 40 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in Fasting Blood Glucose

Timeframe: Baseline to 4 months

Change in Total Cholesterol levels, (mg/dL)

Timeframe: Baseline to 4 months

Change in low-density lipoprotein cholesterol levels, (mg/dL)

Timeframe: Baseline to 4 months

Change in high-density lipoprotein cholesterol levels, (mg/dL)

Timeframe: Baseline to 4 months

Change in Triglycerides levels, (mg/dL)

Timeframe: Baseline to 4 months

Change in Blood Pressure

Timeframe: Baseline to 4 months

Change in Serum Cortisol levels, (μg/dL)

Timeframe: Baseline to 4 months

Change in Serum Uric Acid levels, (mg/dL)

Timeframe: Baseline to 4 months

Trial details

NCT IDNCT07013058

SponsorLiaquat University of Medical & Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-30

View on ClinicalTrials.gov More Metabolic Syndrome trials

Plain-language summary

Who can participate

Age range18 Years – 40 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Fasting Blood Glucose

Timeframe: Baseline to 4 months

Change in Total Cholesterol levels, (mg/dL)

Timeframe: Baseline to 4 months

Change in low-density lipoprotein cholesterol levels, (mg/dL)

Timeframe: Baseline to 4 months

Change in high-density lipoprotein cholesterol levels, (mg/dL)

Timeframe: Baseline to 4 months

Change in Triglycerides levels, (mg/dL)

Timeframe: Baseline to 4 months

Change in Blood Pressure

Timeframe: Baseline to 4 months

Change in Serum Cortisol levels, (μg/dL)

Timeframe: Baseline to 4 months

Change in Serum Uric Acid levels, (mg/dL)

Timeframe: Baseline to 4 months