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

Launched by LIAQUAT UNIVERSITY OF MEDICAL & HEALTH SCIENCES · Jun 5, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a natural extract from the Nigella sativa plant, known as Nisatol®, to see if it can help improve health in perimenopausal women who have metabolic syndrome and high blood pressure. Metabolic syndrome is a group of health issues that can increase the risk of heart disease and diabetes. The researchers want to find out if this extract can reduce blood pressure, improve symptoms related to menopause, and enhance the overall quality of life for these women.

To participate in the trial, women must be aged between 40 and 60 years, experiencing menopausal symptoms, and diagnosed with metabolic syndrome, which means they have at least three specific health markers like high blood pressure or blood sugar levels. Unfortunately, women who are taking hormone replacement therapy, have certain serious health conditions, or are allergic to the Nigella sativa extract cannot join. The trial is not yet recruiting participants, but when it starts, those who qualify will be involved in a study that aims to provide valuable information about the potential benefits of this natural treatment.

Gender

FEMALE

Eligibility criteria

• 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