CompletedNot Applicable

The Effect of Standardized Withania Somnifera Extract on Endocrine, Metabolic, and Psychometric Parameters, in Women With Polyendocrine Metabolic Ovarian Syndrome

Poland28 participantsStarted 2025-01-16

Plain-language summary

The objective of this study is to ascertain the impact of a standardized Withania somnifera extract on endocrine, metabolic, and psychometric parameters in women diagnosed with polyendocrine metabolic ovarian syndrome. The assessment will encompass a range of parameters to determine the severity of depression, stress levels, the quality of sleep, blood pressure, body mass index, and body composition. Additionally, biochemical, metabolic, and endocrine blood parameters in serum will be analysed. The trial's findings may yield a safe and easy-to-use method of adjunctive treatment that could complement therapy in patients with polycystic ovary syndrome.

Who can participate

Age range

18 Years – 45 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: * a diagnosis confirming the presence of polycystic ovary syndrome, * age falling within the closed range of 18-45 years, * absence of pregnancy confirmed by measurement of human chorionic gonadotrophin (β-hCG) levels in serum or urine, or by a gynaecological examination, * not currently breastfeeding, * no implanted metallic devices, such as: prostheses, pacemakers, defibrillators, stents, or metallic sutures in the heart or blood vessels, * no diagnosed epilepsy and no history of epileptic seizures, * not taking anti-epileptic medication, * not taking benzodiazepine-based sedatives, * not taking medicines containing metformin (e.g. Avamina, Formetic, Glucophage, Metformax, Siofor), * not taking preparations containing oestrogens and/or progestogens, * not taking dietary supplements. Exclusion Criteria: * no diagnosis confirming the presence of polycystic ovary syndrome, * age under 18 or over 45, * pregnancy confirmed by measurement of human chorionic gonadotrophin (β-hCG) levels in serum or urine, or by a gynaecological examination, * currently breastfeeding, * having implanted metallic devices, such as: a prosthesis, a pacemaker, a defibrillator, a stent, or a metallic suture in the heart or a blood vessel, * diagnosed epilepsy or a history of epileptic seizures, * taking anti-epileptic medication, * taking benzodiazepine-based sedatives, * taking medicines containing metformin (e.g. Avamina, Formetic, Glucophage, Metformax, Siofor), * taking prepar…

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

Beck Depression Inventory (BDI-II)

Timeframe: Baseline, 3 months, 6 months

Trial details

NCT IDNCT07750899

SponsorMedical University of Lodz

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-20

View on ClinicalTrials.gov More Polyendocrine Metabolic Ovarian Syndrome trials