NCT07013058Completed
Evaluation of a Nigella Sativa Extract (10% Thymoquinone, Nisatol®) in Perimenopausal Women With Metabolic Syndrome
Evaluation of the Efficacy of a Nigella Sativa Extract Standardized to 10% Thymoquinone (Nisatol®) in Improving Metabolic and Blood Pressure Parameters and Quality of Life in Perimenopausal Women With Metabolic Syndrome: A Prospective, Multicenter, Randomized Controlled Clinical Trial
Source: ClinicalTrials.gov · Last updated 30 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 29 May 2025
- Start date
- 15 Jun 2025
- Primary completion date
- 30 Nov 2025
- Lead sponsor
- Liaquat University of Medical & Health Sciences
- Diseases
- High blood pressure
- NCT number
- NCT07013058
What you commit to
- Study type: Interventional
- Participants enrolled: 50
- From 15 Jun 2025 to the primary completion date, 30 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of hormone replacement therapy (HRT)
- Drug or alcohol abuse
Other illness
- Presence of neoplastic diseases
- Presence of liver disease, kidney failure, or diabetes mellitus
- Known hypersensitivity to Nigella sativa or any formulation component
Who the study is looking for
- 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
Age in the registry: 18 years to 40 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ASL Frosinone, Dipartimento di Prevenzione, Coordinator of this site? Confirm its status | Frosinone | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.