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Sponsor: Medical University of Lodz
Conditions: Polyendocrine Metabolic Ovarian Syndrome, Stress, Polycystic Ovarian Syndrome (PCOS), Depression Symptoms
Interventions: Withania somnifera, Active comparator
Countries: Poland
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.
Sex: FEMALE
Age: 18 Years to 45 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
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 preparations containing oestrogens and/or progestogens, * poor general health, severe generalised and systemic diseases, including liver and kidney failure, malabsorption syndromes, * allergy to plants of the nightshade family, * taking dietary supplements.
- Lodz, Poland