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Polyendocrine Metabolic Ovarian SyndromeNCT07750899

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

A study testing Withania somnifera and Active comparator in people with Polyendocrine Metabolic Ovarian Syndrome and Stress, run by Medical University of Lodz at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
What is being tested?
Withania somnifera and Active comparator
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 sitePoland
Study dates
16 Jan 2025to 29 May 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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,
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  • 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.

Who cannot join

  • 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,
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  • 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.

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • Medical University of Lodz

    Lodz

Other trials in Poland

About this study

Official 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

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.

Being tested
Withania somnifera, Active comparator
Medical subject headings
Polycystic Ovary Syndrome, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Withania somniferaDietary 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 comparatorDietary supplement

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

Study groups in NCT07750899
Study groupRoleWhat they receive
Treatment GroupExperimentalWithania somnifera, cholecalciferol, folic acid, and 5-methyltetrahydrofolate
Receives: Dietary Supplement: Withania somnifera
Control groupActive comparatorCholecalciferol, folic acid, and 5-methyltetrahydrofolate
Receives: Dietary Supplement: Active comparator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Beck Depression Inventory (BDI-II)

    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.

    Measured: Baseline, 3 months, 6 months

Secondary outcomes (9)

  1. Perceived Stress Scale (PSS-10)

    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.

    Measured: Baseline, 3 months, 6 months

  2. Pittsburgh Sleep Quality Index (PSQI)

    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.

    Measured: Baseline, 3 months, 6 months

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

    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.

    Measured: Baseline, 3 months, 6 months

  4. Food Frequency Questionnaire (FFQ-6)

    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.

    Measured: Baseline, 3 months, 6 months

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

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

    Measured: Baseline, 3 months, 6 months

  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

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

    Measured: Baseline, 3 months, 6 months

  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

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

    Measured: Baseline, 3 months, 6 months

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

    Blood pressure was measured by a sphygmomanometer.

    Measured: Baseline, 3 months, 6 months

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

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

    Measured: Baseline, 3 months, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2026
  2. Study start16 Jan 2025
  3. Primary completion20 Nov 2025
  4. Study completion29 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Investigator
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07750899
Sponsor's protocol ID
RNN/132/23/KE
Status last verified
Jul 2026
First submitted
10 Jul 2026
Last updated
6 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Zaki AA, Alharbi NM, Almundarij TI, Albarrak SM. Antioxidant and cytokine modulation in PCOS rats protected with probiotics, myo-inositol, and herbal extracts. Vet Med (Praha). 2025 Jun 27;70(6):203-217. doi: 10.17221/116/2024-VETMED. eCollection 2025 Jun.

    PubMed 40778261

  • Saiyed A, Jahan N, Makbul SAA, Ansari M, Bano H, Habib SH. Effect of combination of Withania somnifera Dunal and Tribulus terrestris Linn on letrozole induced polycystic ovarian syndrome in rats. Integr Med Res. 2016 Dec;5(4):293-300. doi: 10.1016/j.imr.2016.10.002. Epub 2016 Oct 19.

    PubMed 28462131

  • Namysl M, Matczak S, Dachowska S, Haraj J, Majcherek E, Sobkowiak M, Bieniek M, Wozniak K. Withania somnifera in Women's Hormonal Modulation: A Narrative Review With Implications for Polycystic Ovary Syndrome and Premenstrual Syndrome. Cureus. 2026 Jan 13;18(1):e101431. doi: 10.7759/cureus.101431. eCollection 2026 Jan.

    PubMed 41694897

  • Stanczyk K, Lopacinska O, Kedzia D, Gawlik-Kotelnicka O. Depressive and Anxiety Symptoms in Women with Polycystic Ovary Syndrome: A Meta-Analysis. J Clin Med. 2026 May 7;15(10):3582. doi: 10.3390/jcm15103582.

    PubMed 42194542

Questions about this trial

What is this clinical trial studying?

A study testing Withania somnifera and Active comparator in people with Polyendocrine Metabolic Ovarian Syndrome and Stress, run by Medical University of Lodz at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Beck Depression Inventory (BDI-II) (time frame: Baseline, 3 months, 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07750899, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.

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