Evaluation of a Nigella Sativa Extract (10% Thymoquinone, Nisatol®) in Perimenopausal Women With … (NCT07013058) | Clinical Trial Compass
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 range
18 Years – 40 Years
Sex
FEMALE
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Fasting Blood Glucose
Timeframe: Baseline to 4 months
2
Change in Total Cholesterol levels, (mg/dL)
Timeframe: Baseline to 4 months
3
Change in low-density lipoprotein cholesterol levels, (mg/dL)
Timeframe: Baseline to 4 months
4
Change in high-density lipoprotein cholesterol levels, (mg/dL)
Timeframe: Baseline to 4 months
5
Change in Triglycerides levels, (mg/dL)
Timeframe: Baseline to 4 months
6
Change in Blood Pressure
Timeframe: Baseline to 4 months
7
Change in Serum Cortisol levels, (μg/dL)
Timeframe: Baseline to 4 months
8
Trial details
NCT IDNCT07013058
SponsorLiaquat University of Medical & Health Sciences