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NCT Number: NCT07750899

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

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.

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Key information

Conditions

Polyendocrine Metabolic Ovarian Syndrome Adnexal Diseases Behavior Behavioral Symptoms Cysts Depression Depression Symptoms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovarian Syndrome (PCOS) Polycystic Ovary Syndrome Stress Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Lodz

Lodz, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Withania somnifera

Dietary Supplement

Withania somnifera (10 mg of withanolides), cholecalciferol (2000 IU), folic acid (0.4 mg), and 5-methyltetrahydrofolate (0.4 mg) orally once daily

Active Comparator

Dietary Supplement

Cholecalciferol (2000 IU), folic acid (0.4 mg), and 5-methyltetrahydrofolate (0.4 mg) orally once daily

Primary outcomes

  1. 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

  1. Perceived Stress Scale (PSS-10)

    Time frame: 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.

  2. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 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.

  3. International Physical Activity Questionnaire - Short Form (IPAQ-SH)

    Time frame: 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.

  4. Food Frequency Questionnaire (FFQ-6)

    Time frame: 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.

  5. Complete blood count parameters: white blood cell count (WBC), red blood cell count (RBC), haemoglobin, haematocrit, and platelets concentration

    Time frame: Baseline, 3 months, 6 months

    The following parameters were analysed to evaluate changes over time within and between treatment groups.

  6. 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

    Time frame: Baseline, 3 months, 6 months

    The following parameters were analysed to evaluate changes over time within and between treatment groups.

  7. 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

    Time frame: Baseline, 3 months, 6 months

    The following parameters were analysed to evaluate changes over time within and between treatment groups.

  8. Blood pressure parameters: systolic (SBP) and diastolic (DBP) blood pressure

    Time frame: Baseline, 3 months, 6 months

    Blood pressure was measured by a sphygmomanometer.

  9. Body composition: skeletal muscle mass, and fat mass

    Time frame: Baseline, 3 months, 6 months

    The assessment of body composition was conducted through the utilisation of Bioelectrical Impedance Analysis (BIA).

Sponsors and collaborators

Lead sponsor

Medical University of Lodz

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Aug 6, 2026
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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