Depression Symptoms, Polycystic Ovarian Syndrome (PCOS), Polyendocrine Metabolic Ovarian Syndrome, Stress
Conditions
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.
Interventions
DIETARY_SUPPLEMENTWithania somnifera
Withania somnifera (10 mg of withanolides), cholecalciferol (2000 IU), folic acid (0.4 mg), and 5-methyltetrahydrofolate (0.4 mg) orally once daily
DIETARY_SUPPLEMENTActive comparator
Cholecalciferol (2000 IU), folic acid (0.4 mg), and 5-methyltetrahydrofolate (0.4 mg) orally once daily
Sponsors
Medical University of Lodz
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Beck Depression Inventory (BDI-II) | 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
| Measure | Time frame | Description |
|---|---|---|
| Perceived Stress Scale (PSS-10) | Baseline, 3 months, 6 months | The Perceived Stress Scale (PSS-10) is a validated 10-item self-reported questionnaire that measures perceived stress over the previous month. Each item is scored from 0 (never) to 4 (very often). The total score ranges from 0 to 40, with higher scores indicating greater perceived stress (worse outcome). This outcome measures the mean change from baseline in PSS-10 total score, where a reduction in score indicates improvement in perceived stress. |
| Pittsburgh Sleep Quality Index (PSQI) | Baseline, 3 months, 6 months | The Pittsburgh Sleep Quality Index (PSQI) is a validated questionnaire assessing subjective sleep quality and disturbances over the previous month. The global score ranges from 0 to 21, with higher scores indicating poorer sleep quality (worse outcome). This outcome measures the mean change from baseline in PSQI global score, where a reduction in score indicates improvement in sleep quality. |
| International Physical Activity Questionnaire - Short Form (IPAQ-SH) | Baseline, 3 months, 6 months | The IPAQ-SH (International Physical Activity Questionnaire - Short Form) is a brief, standardised tool used to assess physical activity over the last 7 days. It captures time spent in walking, moderate activity, vigorous activity, and sitting, allowing researchers to calculate weekly energy expenditure in MET-minutes. |
| Food Frequency Questionnaire (FFQ-6) | Baseline, 3 months, 6 months | The FFQ-6 (Food Frequency Questionnaire - 6-category, 62-item version) is a non-quantitative dietary assessment tool widely used in Polish nutritional research. It records the habitual frequency of consumption of 62 food items across six predefined categories, enabling the identification of dietary patterns. |
| Complete blood count parameters: white blood cell count (WBC), red blood cell count (RBC), haemoglobin, haematocrit, and platelets concentration | Baseline, 3 months, 6 months | The following parameters were analysed to evaluate changes over time within and between treatment groups. |
| 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 | The following parameters were analysed to evaluate changes over time within and between treatment groups. |
| 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 | The following parameters were analysed to evaluate changes over time within and between treatment groups. |
| Blood pressure parameters: systolic (SBP) and diastolic (DBP) blood pressure | Baseline, 3 months, 6 months | Blood pressure was measured by a sphygmomanometer. |
| Body composition: skeletal muscle mass, and fat mass | Baseline, 3 months, 6 months | The assessment of body composition was conducted through the utilisation of Bioelectrical Impedance Analysis (BIA). |
Countries
Poland
Outcome results
None listed