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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Medical University of Lodz
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Beck Depression Inventory (BDI-II)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Control group
Cholecalciferol, folic acid, and 5-methyltetrahydrofolate
Intervention: Active comparator (Dietary Supplement)
Treatment Group
Withania somnifera, cholecalciferol, folic acid, and 5-methyltetrahydrofolate
Intervention: Withania somnifera (Dietary Supplement)
Outcomes
Primary Outcomes
Beck Depression Inventory (BDI-II)
Time Frame: Baseline, 3 months, 6 months
The Beck Depression Inventory (BDI-II) is a validated 21-item questionnaire assessing symptoms of depression. It includes 21 items, each containing four options, scored on a scale of 0 to 3, where 0 indicates the absence of a symptom and 3 its greatest intensity. Higher scores indicate greater symptom severity (worse outcome). This outcome measures the mean change from baseline in BDI-II total score, where a reduction in score indicates improvement in psychological symptoms.
Secondary Outcomes
- Complete blood count parameters: white blood cell count (WBC), red blood cell count (RBC), haemoglobin, haematocrit, and platelets concentration(Baseline, 3 months, 6 months)
- Perceived Stress Scale (PSS-10)(Baseline, 3 months, 6 months)
- Pittsburgh Sleep Quality Index (PSQI)(Baseline, 3 months, 6 months)
- International Physical Activity Questionnaire - Short Form (IPAQ-SH)(Baseline, 3 months, 6 months)
- Food Frequency Questionnaire (FFQ-6)(Baseline, 3 months, 6 months)
- Concentration of metabolic and inflammatory parameters: fasting glucose, fasting insulin, C-reactive protein (CRP), total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides (TG), and alanine aminotransferase (ALT) blood concentration(Baseline, 3 months, 6 months)
- Concentration of endocrine parameters: total testosterone, prolactin, oestrogen, sex hormone-binding globulin (SHBG), luteinising hormone (LH), follicle-stimulating hormone (FSH), cortisol, and dehydroepiandrosterone sulphate (DHEA-S) blood concentration(Baseline, 3 months, 6 months)
- Blood pressure parameters: systolic (SBP) and diastolic (DBP) blood pressure(Baseline, 3 months, 6 months)
- Body composition: skeletal muscle mass, and fat mass(Baseline, 3 months, 6 months)