CompletedNot Applicable

Effect of a Food Supplement Based on Nigella Sativa Seeds Oil and Vitamin E on Glyco-lipid Parameters in Dysglycemic and Dyslipidemic Perimenopausal Women

Italy120 participantsStarted 2024-03-12

Plain-language summary

A total of 120 subjects in one center will be enrolled and will be divided into two treatment groups of 60 subjects each with 1:1 allocation ratio. Permuted block randomization will be used. Active treatment inlcude Nisatol® (developed by PharmExtracta) containing Nigella sativa seeds oil and Vitamin E, 1 capsule soft gel after breakfast and 1 capsule soft gel after dinner for 6 months; Control Intervention is Placebo.

Who can participate

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 (irregular cycles up to intervals of more than 60 days) * FPG values between 100 and 125 mg/dl and confirmation with oral glucose tolerance test (OGTT) * TC values ≥ 200 mg/dl Exclusion Criteria: * neoplastic diseases * liver diseases * renal insufficiency * diabetes mellitus

What they're measuring

Effect on cholesterol and glycemia

Timeframe: 6 months

Trial details

NCT IDNCT06901076

SponsorFondazione IRCCS Policlinico San Matteo di Pavia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-11

View on ClinicalTrials.gov More Perimenopausal Disorder trials