NCT07750899Completed
The Effect of Standardized Withania Somnifera Extract on Endocrine, Metabolic, and Psychometric Parameters, in Women With Polyendocrine Metabolic Ovarian Syndrome
The Effect of Standardized Withania Somnifera Extract on Endocrine, Metabolic, and Psychometric Parameters, in Women With Polyendocrine Metabolic Ovarian Syndrome: a Randomized Active-controlled Trial
Source: ClinicalTrials.gov · Last updated 6 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 28 (actual)
- First submitted
- 10 Jul 2026
- Start date
- 16 Jan 2025
- Primary completion date
- 20 Nov 2025
- Lead sponsor
- Medical University of Lodz
- NCT number
- NCT07750899
What you commit to
- Study type: Interventional
- Participants enrolled: 28
- From 16 Jan 2025 to the primary completion date, 20 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
- taking anti-epileptic medication,
Other illness
- no diagnosis confirming the presence of polycystic ovary syndrome,
- 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,
- poor general health, severe generalised and systemic diseases, including liver and kidney failure, malabsorption syndromes,
- allergy to plants of the nightshade family,
Lab values
- pregnancy confirmed by measurement of human chorionic gonadotrophin (β-hCG) levels in serum or urine, or by a gynaecological examination,
Age
- age under 18 or over 45,
Other
- currently breastfeeding,
- taking benzodiazepine-based sedatives,
- taking medicines containing metformin (e.g. Avamina, Formetic, Glucophage, Metformax, Siofor),
- taking preparations containing oestrogens and/or progestogens,
- taking dietary supplements.
Who the study is looking for
- 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.
Age in the registry: 18 years to 45 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 |
|---|---|---|---|
| Medical University of Lodz Coordinator of this site? Confirm its status | Lodz | Poland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.